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

Catalog Number	AA6114
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn't find other complaints regarding the lot number 9780654.
Event or Problem Description
According to the available information, the event occurred during robotic-assisted gynecological surgery.A urinary catheter is routinely inserted at the beginning of the procedure to empty the bladder and limit the risk of injury.The sterile catheter given directly to a caregiver, who mounts it on the bag without checking the balloon, and then places the device.There was a need to perform a bladder leak test, and the balloon appeared punctured.The catheter does not hold and when it is removed, it is clear that 1cm of the catheter tip is missing.Clinical consequences: longer operating time, as cystoscopy was required, followed by a vaginal approach to check for its presence.Piece not found either in the patient or in the room.
Event or Problem Description
According to the available information, the event occurred during robotic-assisted gynecological surgery.A urinary catheter is routinely inserted at the beginning of the procedure to empty the bladder and limit the risk of injury.The sterile catheter given directly to a caregiver, who mounts it on the bag without checking the balloon, and then places the device.There was a need to perform a bladder leak test, and the balloon appeared punctured.The catheter does not hold and when it is removed, it is clear that 1cm of the catheter tip is missing.Clinical consequences: longer operating time, as cystoscopy was required, followed by a vaginal approach to check for its presence.Piece not found either in the patient or in the room.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaint regarding the lot number 9780654.We received two samples with two different lot numbers on the valve.First catheter with lot number 9587680 (with traceability possibility) we can define this catheter was related to the final product lot 9780654.So the lot number declared in the complaint.Visually this catheter seems conformed, no defect was observed.Balloon was inflated with 10ml of water and stay 5 days inflated without defect observed, balloon was not burst during this period.A second catheter with lot number 9587627 was received with tip missing and balloon burst without missing part.With traceability we can define this catheter was used to packaged final product aa61141002 lot number 9748832.The tip of this second sample was tore, despite this investigation we cannot define root cause of this defect (see photo in attachment in the sample's investigation part).Burst issue of silicone balloon is known but according to the available information we cannot conclude on a specific root cause in this case.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.

• 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: 20457552
• Report Number: 9610711-2024-00292
• Device Sequence Number: 12969392
• Product Code: EZL
• UDI-Device Identifier: 03600040127360
• UDI-Public: 3600040127360
• 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: AA6114
• Device Lot Number: 9780654_AA61141002
• 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: 05/30/2024
• 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