MAUDE Adverse Event Report: COLOPLAST A/S X-FLOW PROSTATECTOMY CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

Model Number 789789789

Device Problem Burst Container or Vessel (1074)

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

Event Date 03/15/2024

Event Type  malfunction  

Event Description

According to the available information when removing the catheter, the nurse discovered a defective balloon.The balloon had a hole in about 3 cm in size.A new catheter was not inserted and no harm to the patient.

Manufacturer Narrative

After receiving this complaint, we searched for other complaints and we found none regarding the lot number 9445830.On 17th may we received documentary investigation from our subcontractor: the probable root cause of this issue was a problem with balloon¿s raw material.Checking the quality databases revealed this type of defect is known and closely monitored.A similar case study was also performed based on same item number and same defect [balloon burst] from march 2020 to march 2024, 45 similar cases were found.A risk management file evaluation was performed and concluded that the risks identified are still acceptable and considered as safe.

• Brand Name: X-FLOW PROSTATECTOMY CATHETER
• Type of Device: INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL
• 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: 19126305
• MDR Text Key: 341371410
• Report Number: 9610711-2024-00084
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040144312
• UDI-Public: 3600040144312
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2024

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 Model Number: 789789789
• Device Catalogue Number: AB6320
• Device Lot Number: 9445830_AB63201002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2023
• 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 Age: 58 YR