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

Catalog Number RJA110

Device Problems Component Incompatible (1108); Fracture (1260)

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

Event Type  malfunction  

Event Description

According to the available information, during the percutaneous procedure the tract was dilated, after a guidewire was inserted, the physician wanted to adjust position of the guidewire and tried to remove the guidewire keeping the dilator; however, the tip of the guidewire got caught on the tip of the dilator which resulted in part of the guidewire peeling off and being left in the patient.The guidewire piece was retrieved successfully.

• 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: 18182893
• MDR Text Key: 328682903
• Report Number: 9610711-2023-00250
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• 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: 11/21/2023

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: RJA110
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2023
• 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