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

Model Number PERITONEAL CATHETER

Device Problems Migration or Expulsion of Device (1395); Infusion or Flow Problem (2964)

Patient Problems Unspecified Infection (1930); Peritonitis (2252); Unintended Radiation Exposure (4565)

Event Date 03/23/2021

Event Type  Injury  

Manufacturer Narrative

Title: salvage of malfunctioning peritoneal dialysis catheters: an algorithm for recanalization and repositioning source: journal of vascular and interventional radiology accepted date: 14 march 2021.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a retrospective observational study evaluated all patients with pd (peritonial dialysis) catheter malfunction that were referred for fluoroscopic intervention with reported catheter inflow and/or outflow obstruction within a 10-month period (between october 2018 and august 2019).This study evaluated two main classes of mechanical catheter failure: malposition and catheter obstruction.All forty patients had the same make and model of pd catheter with documented catheter malfunction: inflow obstruction in 5% (2/41), outflow obstruction in 63% (26/41), both inflow and outflow obstruction in 29% (12/41), and pain without inflow or outflow obstruction in 2% (1/41).The mean time between pd catheter insertion and presentation to the interventional radiology suite was 317 days (range 21-1719 days).Malpositioned catheters were identified during fluoroscopy or by previous imaging such as an abdominal radiograph or ct (computerized tomography).If failure occurred, the pd catheters were salvaged surgically via mini-laparotomy and/or the patient was switched to hemodialysis.Two patients developed complications.One was an exit site infection and the other was culture-negative peritonitis.Both instances were treated with antibiotics per protocol without hospitalization or further complications.Article : salvage of malfunctioning peritoneal dialysis catheters : an algorithm for recanalization and repositioning | authors : li p, choo d, deved v, shah n, shurraw s, zuidema s, samji r, year 2021,journal of vascular & interventional radiology.

• 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: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 11848810
• MDR Text Key: 251644220
• Report Number: 3009211636-2021-00112
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/19/2021

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: PERITONEAL CATHETER
• Device Catalogue Number: PERITONEAL CATHETER
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/19/2021
• 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