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

Catalog Number RCJ108

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problems Hematuria (2558); Unspecified Kidney or Urinary Problem (4503)

Event Date 07/21/2023

Event Type  Injury  

Event Description

According to available information, the patient with this device experienced bleeding.The device assembly was inserted into the kidney over the guidewire.When the doctor tried to withdraw the stylet, advancing the catheter, the connector came off.The catheter with stylet was still inside and hit the kidney.There was bleeding in the membrane in the kidney.The operating procedure continued and was completed.The patient was hospitalized five days for rest.The blood in the urine stopped and the patient was discharged from the hospital.

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 facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to available information, the patient with this device experienced bleeding.The device assembly was inserted into the kidney over the guidewire.When the doctor tried to withdraw the stylet, advancing the catheter, the connector came off.The catheter with stylet was still inside and hit the kidney.There was bleeding in the membrane in the kidney.The operating procedure continued and was completed.The patient was hospitalized five days for rest.The blood in the urine stopped and the patient was discharged from the hospital.

Manufacturer Narrative

The review of the complaint history database, revealed no trends for the lot number 9083907.Checking the quality database revealed one non-conformity on this issue.On 16th august, we received one used sample after investigation, we observed that the connector was disconnected from the stylet.We supposed that the root cause is a gluing problem.On 16th august, we received one used sample after investigation, we observed that the connector was disconnected from the stylet.We supposed that the root cause is a gluing problem.

• 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: 17614822
• MDR Text Key: 321869075
• Report Number: 9610711-2023-00185
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: RCJ108
• Device Lot Number: 9083907_RCJ1081002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2023
• 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
• Patient Outcome(s): Hospitalization