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

Model Number PERITONEAL CATHETER

Device Problem Migration (4003)

Patient Problems Peritonitis (2252); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/25/2021

Event Type  Injury  

Manufacturer Narrative

Title: importance of the creation of a short musculofascial tunnel in peritoneal dialysis catheter placement source: 2022 february 6; 10(4): 1182-1189 doi: 10.12998/wjcc.V10.I4.1182 issn 2307-8960 (online).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a retrospective study evaluated outcomes of peritoneal dialysis (pd) catheter placement with or without a modified musculofascial tunneling procedure using a medtronic 41 cm straight double cuffed pd catheter.Between 2015 and 2019, 222 patients underwent pd catheter placement, patients were divided into two groups, 115 patients with no-tunnel, and 107 patients with tunnel.All patients had at least one radiograph taken in the two-year period following catheter placement.Over the two-year follow-up period, four patients in the no-tunnel group experienced catheter dysfunction due to migration.In addition, both groups had two cases of catheter obstruction due to omental wrapping.Pd was resumed successfully in all four patients following laparoscopic omentectomy.Also, 11 patients in the no tunnel group and 6 patients in the tunnel group had peritonitis, 1 patient in the no tunnel group had abdominal wall leak, 4 patients in the no tunnel group and 2 patients in the tunnel group experienced low efficiency and these led to the cessation of peritoneal dialysis.

• Brand Name: PERITONEAL CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 13943747
• MDR Text Key: 288169645
• Report Number: 3009211636-2022-00082
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PERITONEAL CATHETER
• Device Catalogue Number: PERITONEAL CATHETER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2022
• 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): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male