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

Catalog Number	AA6108
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn't find any other complaint on lot number: 9505100.In november 2024, we received one used sample.After disinfection we can observed that the balloon was folded.Folds balloon during deflation is a known issue and is mentioned on the ifu sh2115: "especially for silicone catheters, balloon folds can be prevented by deflating gently and progressively the balloon.If the patient feels pain when the catheter is removed, the balloon can be slightly re-inflated (make sure the balloon is correctly placed inside the bladder before re-inflating it) and deflated gently once again to remove the folds.According to the investigations performed, quality database was checked and revealed no anomaly in relation to the describe defect.A clinical evaluation was made about this kind of defect and concluded: balloon remanence after complete deflation is a known phenomenon observed in silicone balloon due to balloon defect or misuse.A progressive deflating of the balloon may help reach the balloon original state or at least reduce size of fold(s): several deflating protocols exist, depending on health professional habits.Compliance with our specific recommendations for use is an important aspect for minimizing: risk of incidents e.G.By selecting the correct balloon size, avoiding over-inflation, respecting duration of use and deflating the balloon progressively/passively meaning by gravity without manual syringe aspiration (gonzalgo, 2003).Risk of managing incidents e.G.The balloon that is positioned in the bladder can be slightly re-inflated and deflated gently once again to remove the folds.The evaluation has shown 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.
Event or Problem Description
According to the available information, the nurse experienced resistance and difficulty removing the catheter from the patient.Upon removal it was discovered that the balloon had folded back on itself.This was an isolated incident, resulting in increased pain for the patient.

• 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: 21910667
• Report Number: 9610711-2025-00080
• Device Sequence Number: 7220273
• Product Code: EZL
• UDI-Device Identifier: 03600040126974
• UDI-Public: 3600040126974
• 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
• Report Date (Section B): 04/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AA6108
• Device Lot Number: 9505100_AA61081002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown