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

Catalog Number RJA110

Device Problem Fracture (1260)

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

Event Date 11/04/2023

Event Type  malfunction  

Event Description

According to the available information the white luer lock came off from metallic stylet without difficulty during procedure.The consequence is the loop cannot be formed in the kidney.

Manufacturer Narrative

The product reference rja1101002 lot number 7910694 has been manufactured for (b)(4)pieces in february 2021.This product was made with the intermediate yj161090 "j catheter with mandrin" lot number 7696384 & 7758643.This intermediate yj161090 lot number 7758643 has been manufactured in november 2020 with intermediate product yj161070 lot number 7692595 - 7680641 - 7670540 made in november 2020.These intermediate was made with component yd100470 "mandr-k mandrin corde sde en j" lot number 7650688 made in november 2020.Checking the quality database revealed one non-conformity on this issue: nc (b)(4) "rjc108/208 - complaints white luer is not gluing correctly" opened in july 2022 and closed in december 2022.

Manufacturer Narrative

The review of the complaint history database, revealed no trends for the lot number.Checking the quality database revealed one non-conformity possibly related to this issue: - nc (b)(4) - complaints white luer is not gluing correctly" opened in july 2022 and closed in december 2022.A similar case study was performed over last four years based on same item number and same defect [broke]: no similar case was found.A risk management file evaluation was performed and concluded that residual risks are adequately controlled and reduced as far as possible, and the residual risks associated with the use of the product are acceptable when weighed against the benefits to the patient/user.It is concluded that the risks identified are still acceptable and considered as safe.

• Brand Name: VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER
• Type of Device: UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18359775
• MDR Text Key: 331196924
• Report Number: 9610711-2023-00280
• Device Sequence Number: 1
• Product Code: LJE
• 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
• Type of Report: Initial,Followup
• Report Date: 05/24/2024

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 Catalogue Number: RJA110
• Device Lot Number: 7910694_RJA1101002
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1