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
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 tw(b)(4): "pb ballons (bulles + agglutinés)" opened in (b)(6) 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.
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
After receiving this complaint, we searched for other complaints and we found none regarding the lot number 9541019.We received one used sample.After disinfection we observed that the balloon was burst without missing part.According to the investigations done quality databases was checked and revealed one non-conformity in relation to the described defect and a corrective and preventive action: - (b)(4): "pb balloons (bulles + agglutinés)" opened on (b)(6) 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.A similar case study was performed based on ab61xx, balloon burst form (b)(6) 2020 to (b)(6) 2024, (b)(4) similar cases were found.The evaluation has showed that risks are adequately controlled and reduced as far as possible in the state of art.Based on this, we can conclude that residual risks are adequately controlled and reduced as far as possible, and the residual risks associated with the use of the product are acceptable when weighed against the benefits to the patient/user.
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.

• 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: 19335144
• Report Number: 9610711-2024-00119
• Device Sequence Number: 3009733
• 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,Followup
• Report Date (Section B): 10/03/2024

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
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown