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

Catalog Number	AB6C20
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn't find other complaint regarding the lot number 9634395.B3: estimated date.
Event or Problem Description
According to the available information, double current bladder catheter insertion without difficulty and the balloon inflated to 15cc of water.Two washing pockets go through easily but on the third the patient is in pain.The liquid no longer flows into the collection bag and it is attempted to unclog thinking it could be a blood clot in the bladder.It was unable to remove the liquid with a syringe.The catheter was repositioned and the liquid leaves.The catheter came out with the balloon empty.The catheter was tested which leaked very slowly and was split.A new catheter was inserted successfully.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn't find other complaint regarding the lot number 9634395 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 monitored.No corrective action will be implemented as our trend is not increasing and the threshold is not exceeded.A similar case study was perfomed based on same dhf: prostatic siliconce catheter, same defect "burst" over last four year, 123 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.It is concluded that the risks identified are still acceptable and considered as safe.
Event or Problem Description
According to the available information, double current bladder catheter insertion without difficulty and the balloon inflated to 15cc of water.Two washing pockets go through easily but on the third the patient is in pain.The liquid no longer flows into the collection bag and it is attempted to unclog thinking it could be a blood clot in the bladder.It was unable to remove the liquid with a syringe.The catheter was repositioned and the liquid leaves.The catheter came out with the balloon empty.The catheter was tested which leaked very slowly and was split.A new catheter was inserted successfully.

• 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: 20592238
• Report Number: 9610711-2024-00304
• Device Sequence Number: 21031747
• Product Code: EZL
• UDI-Device Identifier: 03600040146354
• UDI-Public: 3600040146354
• 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): 02/21/2025

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: AB6C20
• Device Lot Number: 9634395_AB6C201002
• 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: 11/01/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2024
• 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
• Patient Sex: Unknown