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

Catalog Number	AA6116
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: estimated date.
Event or Problem Description
According to the available information, the catheter placed for the bladder drainage and hydric balance, after a soft involuntary patient traction, it broke.Part of catheter remained in the urinary tract.It was necessary to remove the part through a cystoscopy.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we found none regarding the lot number 9591024.Documentary investigation was done and no issue were registered during production.Without sample we cannot define the root cause of this issue.Checking the quality database revealed one change control (b)(4) "packaging - addition of longitunal precuts" opened on (b)(6) 2013 and closed on (b)(6) 2014.- about the technical specification minimum expected for tensile test on catheter part: tip ch12 = 20n 5 samples were tested with ch18 and all results are conformed.Minimal value observed: 29.909 n average value observed: 41.695 n maximal value observed: 49.863 n these results showed our glueing step was in accordance with our specification.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 on folysil product, defect: tip tore from (b)(6)2020 to (b)(6) 2024: 19 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, the catheter placed for the bladder drainage and hydric balance, after a soft involuntary patient traction, it broke.Part of catheter remained in the urinary tract.It was necessary to remove the part through a cystoscopy.

• 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: 20267502
• Report Number: 9610711-2024-00252
• Device Sequence Number: 7240347
• Product Code: EZL
• UDI-Device Identifier: 03600040127490
• UDI-Public: 3600040127490
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 03/10/2025

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: 9478196_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: 09/20/2024
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2023
• 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