MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL SILICONE CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

Catalog Number	AA6114
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaint regarding the lot number 9558587.The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.B3: date is unknown.
Event or Problem Description
According to the available information, the balloon burst two days after the catheter was inserted, and the catheter came out.The patient suffered no harm.
Event or Problem Description
According to the available information, the balloon burst two days after the catheter was inserted, and the catheter came out.The patient suffered no harm.
Additional Manufacturer Narrative
In (b)(6) 2025, we received one used sample.After decontamination, at visual examination we see that the balloon was burst without missing part.After receiving this complaint, we searched for other complaint and we didn't find other complaint regarding the lot number 9558587 on the same defect.This product was made by our subcontractor which was informed about this issue.Balloon burst issue 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 criq247, risk identified 11500 (hazardous situation: catheter balloon cannot stay inflated or burst).For the risk 11500 with root cause 'balloon defect causing balloon burst', 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.

• Brand Name: FOLYSIL SILICONE 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: 21875309
• Report Number: 9610711-2025-00076
• Device Sequence Number: 7865218
• Product Code: EZL
• UDI-Device Identifier: 03600040127360
• UDI-Public: 3600040127360
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K233411
• 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): 07/14/2025

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: AA6114
• Device Lot Number: 9558587_AA61141002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2025
• 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: 04/21/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2024
• 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