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

Model Number PERITONEAL CATHETER

Device Problem Obstruction of Flow (2423)

Patient Problems Unspecified Infection (1930); Peritonitis (2252)

Event Type  Injury  

Manufacturer Narrative

Title: "comparison between the fixation of peritoneal dialysis catheters to the peritoneal wall and the conventional placement technique: clinical experience and follow-up of a new implant technique for peritoneal dialysis catheters." source: seminars in dialysis, volume 27, 2014 (e42¿e47).Article number: 4.Date of publication: 2014, july-august.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed, peritoneal dialysis catheters were implanted in 41 patients wherein peritoneal dialysis treatments were performed for more than three months and had been subject to capd (continuous ambulatory peritoneal dialysis).In the first 2 years, 16 patients were implanted using the conventional placement technique.In the 3 years from 2006, 25 patients were implanted using a method of fixing the catheter downward in the peritoneal cavity (fixation technique).Mechanical complications as those that were not infectious complications related to the catheter (including peritonitis, exit-site infection, and tunnel infection), and those that were neither medical nor psychosocial.Infectious complications related to pd catheter were exit-site infection, tunnel infection, and peritonitis.Mechanical complications related to the insertion procedure, the presence of dialysate in the peritoneum, problems secondary to abdominal events, catheter accidents, and cuff extrusion did not occur with either the fixation or conventional technique.Infectious complications were not significantly different among the fixation or conventional technique for exit-site infections, tunnel infections, and peritonitis.Mechanical complications due to catheter obstruction occurred in one case in the fixation technique group and in two cases in the conventional group.

• 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
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire st.; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 8566761
• MDR Text Key: 143616108
• Report Number: 3009211636-2019-00107
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2019
• 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): Required Intervention