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

Catalog Number	AA6112
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information, when removing the indwelling catheter, it was impossible to deflate the balloon.The balloon was not checked beforehand.Catheterization without problems, but there was no urine immediately, so the decision was made to inflate the balloon with 10ml of water to be able to mobilize the catheter.There was no problem inflating it.The catheter was immediately removed, but the balloon could not be deflated, and the decision was made to cut the catheter.Water drained smoothly and the catheter was removed without forcing.The patient experienced no pain.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint regarding the lot number.The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we found none regarding the lot number 9792211.On 13th june 2025 we did not received sample.Without sample we cannot do more than documentary investigation which revealed no anomaly registered during production.However, deflation issue of silicone balloon is known but according to the available information we cannot conclude on a specific root cause in this case.According to the information known 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 folysil product, defect deflation difficult/impossible between march 2021 and march 2025, 58 similar cases were found.
Event or Problem Description
According to the available information, when removing the indwelling catheter, it was impossible to deflate the balloon.The balloon was not checked beforehand.Catheterization without problems, but there was no urine immediately, so the decision was made to inflate the balloon with 10ml of water to be able to mobilize the catheter.There was no problem inflating it.The catheter was immediately removed, but the balloon could not be deflated, and the decision was made to cut the catheter.Water drained smoothly and the catheter was removed without forcing.The patient experienced no pain.

• 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: 21868134
• Report Number: 9610711-2025-00072
• Device Sequence Number: 7888659
• Product Code: EZL
• UDI-Device Identifier: 03600040127230
• UDI-Public: 3600040127230
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/30/2025

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: AA6112
• Device Lot Number: 9792211_AA61121002
• 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: 04/18/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2024
• 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