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

Catalog Number	AB6120
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information when checking the correct positioning of the balloon, the balloon was inflated to 50cc when the balloon burst.Patient experienced pain and non-irrigated hematuria.
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.No other complaints were found for the lot number.Nc (b)(4): "pb ballons (bulles + agglutinés)" opened in 16 january 2023.For this nc, the used of clumped balloons should be responsible of some weakness on the balloon and being responsible of bursting.Monitoring capa-000152: "balloon issues on folysil and silicone prostatic catheters".The trending for balloon bursting is specifically monitored.

• 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: 19335134
• Report Number: 9610711-2024-00118
• Device Sequence Number: 6942579
• Product Code: EZL
• UDI-Device Identifier: 03600040143711
• UDI-Public: 03600040143711
• 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
• Report Date (Section B): 05/16/2024

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: AB6120
• Device Lot Number: 9541019_AB61201002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2024
• Date Device Manufactured: 01/05/2024
• 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