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

Catalog Number	AB6318
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	Pain (1994); Hematuria (2558)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information the balloon had torn.Patient was re-catheterized with slight hematuria.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn't find other complaints regarding the lot number 8931551.This product was made by our subcontractor which was informed about this issue.We received a documentary investigation from our subcontractor: the probable root cause of this issue was a problem with balloon¿s raw material.We received one used sample.We observed that balloon was burst without missing part.Morever, the catheter at the funnel level is broken.Checking the quality databases revealed this type of defect is known and closely monitored a similar case study was performed based on same item number ab63xx, defect: burst, over the last four years: 33 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
• Common Device Name: INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 19154594
• Report Number: 9610711-2024-00091
• Device Sequence Number: 17993701
• Product Code: EZL
• UDI-Device Identifier: 03600040144183
• UDI-Public: 3600040144183
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: AB6318
• Device Lot Number: 8931551_AB63181002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 07/01/2024
• Date Device Manufactured: 12/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown