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	01/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, balloon was not able to be emptied with 20cc syringes.Balloon remained in place for about 10 hours and needed to be removed under ultrasound in the consulting room over a 2-hour period with subsequent antibiotic prophylaxis.
Additional Manufacturer Narrative
The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.Correction: a2: updated with the patient's age.
Event or Problem Description
According to the available information, balloon was not able to be emptied with 20cc syringes.Balloon remained in place for about 10 hours and needed to be removed under ultrasound in the consulting room over a 2-hour period with subsequent antibiotic prophylaxis.
Additional Manufacturer Narrative
A lot number is available in the description, it is a lot number used in the unit but the incriminated lot number is not known.We have checked the lot number on the description and based our documentary investigation on this lot, even if it's not the incriminated lot.We searched for other complaint regarding the lot number in description and we didn't find other complaint regarding the lot number 9792211.On 18th february 2025, we received one used sample.We only receive one part of tube without valve so no test of inflation/deflation can be done.The tube of the catheter was cut probably with a sharp material.However according to the information received it was mentioned that the balloon was inflated with 12ml of water, instead of the 10ml as mentioned on the product.So this situation is considered as a misuse.Checking the quality databases revealed no anomaly in relation to the described defect.A rmf evaluation was performed based on criq247, risk identified 12606 (hazardous situation: catheter balloon cannot be deflated (or with difficulty).The evaluation has shown that risks are adequately controlled and reduced as far as possible in the state of art level (except risk 11500).Based on this, we can conclude that residual risks except for risk 11500 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 folysil silicone catheter, on same defect "balloon inflation difficult/impossible" from january 2021 to january 2025: 55 similar cases were found.
Event or Problem Description
According to the available information, balloon was not able to be emptied with 20cc syringes.Balloon remained in place for about 10 hours and needed to be removed under ultrasound in the consulting room over a 2-hour period with subsequent antibiotic prophylaxis.

• 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: 21439863
• Report Number: 9610711-2025-00035
• Device Sequence Number: 17271245
• 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,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AA6112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• 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; Not provided
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 02/27/2025; 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Unknown