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

Catalog Number	AA6112
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
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 9041085.
Event or Problem Description
According to the available information, when attempting to remove the catheter the balloon was unable to be deflated with a syringe.To deflate the balloon the balloon was pierced by echography by abdominal punction.The patient had to be sedated to allow bladder punction.The exit from the post-intervention room was delayed.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaint regarding the lot number 9041085.On 25th october, we received one used sample.After decontamination, we observed that the balloon was burst, pierced by the medical team because it could not deflate the balloon.In addition, the valve was cut off.In this situation, the sample does not allow us to identify a root cause explaining the difficulty of deflation.Balloon deflation issue is known but 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.A similar case study was performed based on folysil silicone catheter, same defect:"balloon deflation difficult/impossible" over last four year: 52 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.
Event or Problem Description
According to the available information, when attempting to remove the catheter the balloon was unable to be deflated with a syringe.To deflate the balloon the balloon was pierced by echography by abdominal punction.The patient had to be sedated to allow bladder punction.The exit from the post-intervention room was delayed.

• 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: 20521847
• Report Number: 9610711-2024-00297
• Device Sequence Number: 9105416
• Product Code: EZL
• UDI-Device Identifier: 03600040127230
• UDI-Public: 3600040127230
• 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: AA6112
• Device Lot Number: 9041085_AA61121002
• 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: 10/24/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• 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