MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. UNKNOWN PERITONEAL CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number UNKNOWN PERITONEAL CATHETER

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Peritonitis (2252)

Event Type  Injury  

Manufacturer Narrative

Title: comparing the incidence of catheter-related complications with straight and coiled tenckhoff catheters in peritoneal dialysis patients¿a single-center prospective randomized trial source: peritoneal dialysis international, volume 35, july 2015 (443¿449) article number: 4; date of publication: 13 october 2013.If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

According to literature source of study performed, straight and coiled catheters were used in 189 patients with end-stage renal disease.Of the 189 patients, 99 were randomized to the straight catheter group, whose members all received a 41-cm double-cuffed straight catheter with a 15.5-cm intraperitoneal segment with a straight tip.The other 90 patients were randomized to the coiled catheter group, whose members all received a 62-cm double-cuffed catheter with a 17-cm intraperitoneal segment with a coiled tip.Catheter tip migration and omental wrapping were the most common causes of catheter dysfunction.Catheter dysfunction was the most common noninfectious complication in 23 of 189 patients (12.2%).Catheter dysfunction was significantly more common in the group who used coiled catheters (17.8% of patients) versus 7 of 99 patients who used straight catheters (7.1%).Catheters were removed in 9 patients (4.8%) because of peritonitis, leaks (1.1%) and catheter-tip migration (0.5%).

• Brand Name: UNKNOWN PERITONEAL CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 8630715
• MDR Text Key: 145738169
• Report Number: 3009211636-2019-00126
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PERITONEAL CATHETER
• Device Catalogue Number: UNKNOWN PERITONEAL CATHETER
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 05/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other