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

Catalog Number AB6022

Device Problem Burst Container or Vessel (1074)

Patient Problems Pain (1994); Genital Bleeding (4507)

Event Date 02/13/2024

Event Type  Injury  

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 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.

• 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: 18921685
• MDR Text Key: 337873286
• Report Number: 9610711-2024-00066
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040143360
• UDI-Public: 3600040143360
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: AB6022
• Device Lot Number: 9067760_AB60221002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2024
• Date Device Manufactured: 03/08/2023
• 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 Outcome(s): Required Intervention