Material Failure of Silicone Catheter Lines: A Retrospective Review of Partial and Complete Ruptures in 553 Patients.
OBJECTIVE
This present study reports the frequency and outcome of material failure of the silicone catheter lines of a port device implanted in the upper arm during a 5-year period.


METHODS
From 2006 to 2011, a total of 553 patients had a port device implanted percutaneously in the upper arm. In the spring of 2013, several instances of material failure led to device withdrawal. At that time, 39 patients (7.1%) with the specific device in situ were still alive, and 36 of these patients agreed to removal. Linear mixed-effects models were used to analyze the log-transformed device dwell time. Random effects were modeled using group variables. The mean estimated values and their corresponding 95% CIs were reported. Nominal p values were reported, and two-sided p < 0.05 was considered to denote statistical significance.


RESULTS
Among the 553 patients, material failure was noticed in 19 patients (3.4%), with a mean estimated dwell time of 243 days (95% CI, 104-570 days). Specifically, complete rupture occurred in 10 patients (1.8%) after a mean of 322 days (95% CI, 95-1089 days), partial rupture occurred in eight patients (1.4%) after a mean of 190 days (95% CI, 61-596 days), and disconnection occurred in one patient (0.2%) 8 days after device placement.


CONCLUSIONS
The frequency of catheter line rupture was 3.4%. The mean estimated interval to rupture was less than a year, with an increasing probability of rupture noted in association with a longer dwell time. The exact cause of material failure remains unexplained, and further investigation of the mechanical properties contributing to rupture is required. Insight into the safety profile of these devices is needed to avoid potentially severe injury and improve the management of affected patients.
1 Department of Diagnostic and Interventional Radiology and Nuclear Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.|2 Section of Pediatric Radiology, Department of Diagnostic and Interventional Radiology and Nuclear Medicine, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany.
Jasmin D
JD
Busch
3 Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Maren
M
Vens
1 Department of Diagnostic and Interventional Radiology and Nuclear Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.|2 Section of Pediatric Radiology, Department of Diagnostic and Interventional Radiology and Nuclear Medicine, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany.
Jochen
J
Herrmann
1 Department of Diagnostic and Interventional Radiology and Nuclear Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Gerhard
G
Adam
1 Department of Diagnostic and Interventional Radiology and Nuclear Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Harald
H
Ittrich
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004868:Equipment Failure / Q000706:statistics & numerical data*; D005260:Female; D005471:Fluoroscopy / Q000706:statistics & numerical data*; D005858:Germany / Q000453:epidemiology; D006801:Humans; D008297:Male; D008422:Materials Testing / Q000706:statistics & numerical data*; D008875:Middle Aged; D010690:Phlebography / Q000706:statistics & numerical data*; D012828:Silicones / Q000737:chemistry*; D062666:Vascular Access Devices / Q000706:statistics & numerical data*; D055815:Young Adult
D012828:Silicones
arm port system; central venous access; complications; interventional radiology; percutaneous placement