MAUDE Adverse Event Report: COLOPLAST A/S VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER; UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE

Catalog Number RJA208

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 03/11/2024

Event Type  malfunction  

Event Description

According to the available information upon removal of the mandarin the catheter would come back with it.

• Brand Name: VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER
• Type of Device: UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE
• 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: 19116715
• MDR Text Key: 341004531
• Report Number: 9610711-2024-00083
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 03600040257883
• UDI-Public: 3600040257883
• 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: 04/16/2024

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: RJA208
• Device Lot Number: 9579220_RJA2081002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2024
• Date Device Manufactured: 01/18/2024
• 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