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

Catalog Number	AA6116
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, indwelling catheterization for caesarean section and the catheter was intact when checked before catheterization.There was doubt about a blocked catheter during the procedure (traces of blood but no urine).The catheter was removed and replaced by another catheter.We 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.We received the incriminated sample.After disinfection, a visual inspection was performed, tip was tore.According to our historical data this issue was known and was probably tore during packaging opening.Based on investigation performed, checking the quality database revealed one change control cc (b)(4) "packaging - addition of longitunal precuts" opened on september 2013 and closed on january 2014.Since implantation of change control (b)(4), it is strongly recommended to use longitudinal precuts.Transversal precut is not recommended and should be used with great caution.A similar case study was performed based on folysil silicone catheter on same defect "distal end broken" over last four year, 32 similar cases were found.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.
Event or Problem Description
According to the available information, indwelling catheterization for caesarean section and the catheter was intact when checked before catheterization.There was doubt about a blocked catheter during the procedure (traces of blood but no urine).The catheter was removed and replaced by another catheter.We 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: 20455562
• Report Number: 9610711-2024-00291
• Device Sequence Number: 8559283
• 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): 02/21/2025

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: AA6116
• Device Lot Number: 9690320_AA61161002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• 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: 02/21/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown