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

Catalog Number	AB6420
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we found none regarding the lot number.The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.
Event or Problem Description
According to the available information, the patient had no indwelling catheterization.The patient presented a bladder globe.He had an enlarged prostate that was about to be resected.The nurse went through the natural route and when checking the balloon, the nurse found no asymmetry or other phenomena.The nurse used a lubricant, then inflated the balloon with water ppi.The nurse did not need to use the irrigation way.The nurse filled the balloon with about 50ml and placed the catheter and a later time, when the patient was getting up, the catheter fell and noticed that the balloon was broken / cracked.There were no clinical consequences for the patient, and another catheter was inserted later that day.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we found none regarding the lot number 7948572.Balloon components were made with mix reference (b)(4) lot number 7468832.It was prepared from a mix of raw materials (b)(6) lot number 1912190153 and (b)(6) lot number 2005050159.These lot numbers were analysed at our qa production laboratories and were conformed.On (b)(6) 2025, after disinfection it was observed that the balloon was burst without missing part.Burst 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 rmf evaluation was performed based on (b)(6), risk identified 11500 (hazardous situation: "catheter balloon cannot stay inflated or burst").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.It is concluded that the risks identified are still acceptable and considered as safe.A similar case study was performed on prostatic silicone catheter, on the same defect "balloon burst" from (b)(6) 2021 to (b)(6) 2025, (b)(4) similar cases were found.
Event or Problem Description
According to the available information, the patient had no indwelling catheterization.The patient presented a bladder globe.He had an enlarged prostate that was about to be resected.The nurse went through the natural route and when checking the balloon, the nurse found no asymmetry or other phenomena.The nurse used a lubricant, then inflated the balloon with water ppi.The nurse did not need to use the irrigation way.The nurse filled the balloon with about 50ml and placed the catheter and a later time, when the patient was getting up, the catheter fell and noticed that the balloon was broken / cracked.There were no clinical consequences for the patient, and another catheter was inserted later that day.

• 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: 21485132
• Report Number: 9610711-2025-00040
• Device Sequence Number: 8546661
• Product Code: EZL
• UDI-Device Identifier: 03600040144770
• UDI-Public: 3600040144770
• 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): 06/06/2025

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 Expiration Date: 03/31/2026
• Device Catalogue Number: AB6420
• Device Lot Number: 7948572_AB64201002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• 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 Age: 64 YR
• Patient Sex: Male