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

Catalog Number	AA6116
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information, indwelling catheterization for caesarean section, the catheter was intact and checked before catheterization.Doubt about a blocked catheter during the procedure (traces of blood but no urine), catheter removed and replaced by another catheter.It was discovered that the distal end of the catheter (cut cleanly at the distal limit of the balloon) was missing at the time of removal.Risks of infection, risk of anaphylaxis, new operation for the patient with anesthetic risk, psychological trauma.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and found none regarding the lot number 9690320 on the same defect.On september, we received one used sample for two complaints (b)(4) (drainage issue) & (b)(4) (tip missing).The investigation regarding the tip missing is done in the corresponding complaint.The inflation / deflation functionality were tested and we noted that the balloon was assymetric and out of specification according to our specification (docaq22014-asymétrie ballon vv-0373154).This assymetry could make it difficult or even impossible urine drainage.Balloon asymetry issue is know but, in this case, according to the available information we cannot conclude on a specific root cause.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.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.A similar case study was perfomed based on folysil silicone catheter, same defect "performance drainage" over last four year, 20 similar cases were found.
Event or Problem Description
According to the available information, indwelling catheterization for caesarean section, the catheter was intact and checked before catheterization.Doubt about a blocked catheter during the procedure (traces of blood but no urine), catheter removed and replaced by another catheter.It was discovered that the distal end of the catheter (cut cleanly at the distal limit of the balloon) was missing at the time of removal.Risks of infection, risk of anaphylaxis, new operation for the patient with anesthetic risk, psychological trauma.

• 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: 20455025
• Report Number: 9610711-2024-00290
• Device Sequence Number: 9232268
• Product Code: EZL
• UDI-Device Identifier: 03600040127490
• UDI-Public: 3600040127490
• 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): 03/12/2025

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: AA6116
• Device Lot Number: 9690320_AA61161002
• 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: 10/15/2024
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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