MAUDE Adverse Event Report: COLOPLAST A/S VORTEK J PERCUTANEOUS NEPHROSTOMY CATHETER

Catalog Number RCJ108

Device Problems Solder Joint Fracture (2324); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2024

Event Type  malfunction  

Event Description

According to the available information the mandrel stiffening the catheter could not be removed.The cap became detached from the body of the mandrel.A catheter change was completed.

• Brand Name: VORTEK J PERCUTANEOUS NEPHROSTOMY CATHETER
• Type of Device: NEPHROSTOMY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): CMF-SARLAT; 9 avenue edmond rostand; sarlat-la-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 19015227
• MDR Text Key: 339123944
• Report Number: 9610711-2024-00076
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 03600040256381
• UDI-Public: 3600040256381
• Combination Product (y/n): N
• PMA/PMN Number: K211911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RCJ108
• Device Lot Number: 9536437_RCJ1081002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2024
• Date Device Manufactured: 12/15/2023
• 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