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

Catalog Number RCJ109

Device Problem Fracture (1260)

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

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.

Event Description

According to the available information, the guide rod was defective.The white cone for uncoupling / turning was not firmly connected to the guide rod.Removal was only possible with a clamp.There were no patient complications.

Manufacturer Narrative

B3: estimated date.B5: the additional four times were captured under separate reports.After receiving this complaint, we searched for other complaints [from separate incidents] and we didn't find any other complaint regarding the lot number 8916283.Checking the quality database revealed one non-conformity that is ongoing about gluing issue on the white luer lock.A similar case study was performed over the last four years based on same item number and same item defect [broken], no similar case was found.A risk management framework evaluation concluded that the risks identified are still acceptable and considered as safe.

Event Description

According to the available information, the issue occurred approximately five times.

• 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: 18288296
• MDR Text Key: 330155533
• Report Number: 9610711-2023-00270
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K211911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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: RCJ109
• Device Lot Number: 8916283_RCJ1091002
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2022
• 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