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

Model Number UNKNOWN PERITONEAL CATHETER

Device Problems Fluid/Blood Leak (1250); Migration or Expulsion of Device (1395)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240)

Event Date 09/04/2018

Event Type  Injury  

Manufacturer Narrative

Title: peritoneal dialysis catheter placement, outcomes and complications source pediatric surgery international, volume 34, 2018 (1239¿1244).Date of publication: 4 september 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed at two institutions, 14% of patients developed leakage, 10% of patients developed infection, 6% of patients had adhesions requiring surgery, 6% of patients had catheter migration and 10% of patients had associated ventral hernias out of the 157 catheters placed ranging in age from 1 day to 23 years.Of the catheters that required replacement, 36% of patients had leakage, 14% of patients had catheter migration, 5% of patients had adhesion, 18% of patients were infected, and 5% of patients had a hernia.The catheters used were curl-type peritoneal dialysis catheters or catheters of a very similar type.The patients that underwent an omentectomy were 75% less likely to require a catheter replacement.It was found out that laparoscopic intervention resulted in catheter salvage, lateral exit sites may be a risk factor for catheter migration in some patients, and omentectomy is associated with longer pd (peritoneal dialysis) catheter survival.Laparoscopic salvage of dysfunctional catheters may be a valuable adjunct in management.

• 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: 8544589
• MDR Text Key: 142910180
• Report Number: 3009211636-2019-00103
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2019

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: 04/05/2019
• Initial Date FDA Received: 04/24/2019
• 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