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

Catalog Number	AB6022
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	Pain (1994); Genital Bleeding (4507)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.No other complaints were found for the lot number.One non-conformity in relation to the described defect and a corrective and preventive action: - nc tw(b)(4): 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.On november 8th we have not received sample.Upon receipt complaint will be reopened and updated.
Event or Problem Description
According to the available information the patient was operated for prostate resection.The balloon of the catheter burst on rising.Patient was catheterized again but, in the morning, the balloon of the new catheter burst.Patient experienced pain and bleeding from the penis.Patient was re-catheterized with a crutch catheter.
Additional Manufacturer Narrative
A similar case study was performed based on same item number ab60 and defect described [burst] over the last four years; 5 similar cases were found.A risk management file evaluation was performed and concluded 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.It is 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 (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: 18921685
• Report Number: 9610711-2024-00066
• Device Sequence Number: 6476633
• Product Code: EZL
• UDI-Device Identifier: 03600040143360
• UDI-Public: 3600040143360
• 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): 07/03/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: AB6022
• Device Lot Number: 9067760_AB60221002
• 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: 03/18/2024
• Supplement Report FDA Received Date: 07/03/2024
• Date Device Manufactured: 03/08/2023
• 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: Required Intervention
• Patient Sex: Unknown