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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn't find other complaints regarding the lot number 9143103 on the same defect.
Event or Problem Description
According to the available information, on (b)(6), a bladder catheter was inserted at the end of the day.The morning of (b)(6), during the nurse's rounds, the nurse noticed urine in the patient's bed.She found the catheter exteriorized and the balloon ruptured.There were no consequences for the patient.This was an isolated incident.
Event or Problem Description
According to the available information, on (b)(6), a bladder catheter was inserted at the end of the day.The morning of (b)(6), during the nurse's rounds, the nurse noticed urine in the patient's bed.She found the catheter exteriorized and the balloon ruptured.There were no consequences for the patient.This was an isolated incident.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn't find other complaint regarding the lot number 9143103 on the same defect.Balloons components were made from 2 different batches of vs014150 (reference) and the lot number were 8807787 & 8789748 it was prepared from a mix of raw materials saa339 lot number 2203150048 & 2209060067 & 2202080081 and sa7117 lot number 2205240137.These lots number were analysed at our qa production laboratories and were conformed.We received one used sample with balloon burst.Balloon was burst, and one part of the balloon has completely detached from the catheter during disinfection.In this condition it was difficult to check the integrity of the balloon.Bursting issue of silicone balloon is known but according to the available information we cannot conclude on a specific root cause in this case.Quality database was checked and revealed a corrective and preventive action: capa-000152."balloon issues on folysil and silicone prostatic catheters" was opened and monthly monitoring.No corrective action will be implemented as our trend is not increasing and the threshold is not exceeded.A similar case study was performed based on product prostatic catheter, defect balloon burst from (b)(6) 2021 to (b)(6) 2025: 121 similar cases were found.The evaluation has showed that risks are adequately controlled and reduced as far as possible in the state of art level.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.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 Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 21218671
• Report Number: 9610711-2025-00017
• Device Sequence Number: 3326534
• 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): 03/21/2025

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: 9143103_AB63181002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2025
• 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: 01/23/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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
• Patient Sex: Unknown