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

Catalog Number	AA6106
Medical Device Problem Codes	Burst Container or Vessel (1074); Fracture (1260); Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted.Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.B3: estimated date.
Event or Problem Description
According to the available information, when filling the balloon to 1.5 ml, there was an accidental exit of the bladder catheter and a rupture of the balloon and tip.The tip was missing and estimated to be approximately 1 cm in size.The patient underwent two intraoperative x-rays and an exploratory cystoscopy.No foreign body was found.The extra procedures and the general anesthesia time added length to the procedure.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we found none regarding the lot number 9940965 for the same defect.This catheter reference was made with one tube component which composed the ¿body¿ of the catheter.Then the balloon is glued around the tube.The tip is not glueing, so it cannot be unglueing, there are no structural weaknesses linked to assembly on this part of the catheter.This kind of defect may be due to an excess of force applied on the medical device or a sharp instrument that damaged catheter.Once a silicone catheter is damaged, even slightly, the material becomes more fragile and tears more easily.In the photo, the break looks clean and regular, which may correspond to a cut product.The balloon has probably deflated as a result.But without the sample and the additional information requested, we cannot investigate further and verify these hypothesis.According to the informations known quality database was checked and revealed no anomaly in relation to the describe defect.A similar case study was performed based on folysil catheter defect distal tip broken, over last four years: 43 similar cases were found.The evaluation has showed 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, when filling the balloon to 1.5 ml, there was an accidental exit of the bladder catheter and a rupture of the balloon and tip.The tip was missing and estimated to be approximately 1 cm in size.The patient underwent two intraoperative x-rays and an exploratory cystoscopy.No foreign body was found.The extra procedures and the general anesthesia time added length to the procedure.

• 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: 21643497
• Report Number: 9610711-2025-00055
• Device Sequence Number: 7614826
• Product Code: EZL
• UDI-Device Identifier: 03600040126844
• UDI-Public: 3600040126844
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 06/26/2025

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: AA6106
• Device Lot Number: 9940965_AA61061002
• 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: 03/19/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2024
• 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