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

Catalog Number	AA6106
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
According to available information, this device was difficult to deflate.In an attempt to remove the device, the balloon was not deflating despite the catheter being cut in half.The urologist punctured the balloon using a guidewire.No other adverse patient effects were reported.
Additional Manufacturer Narrative
This product was made by our subcontractor which was informed about this issue.No other complaint was found regarding the lot number 8796891.The documentary investigation revealed no defect recording during manufacturing, 100% were tested and conformed.Checking the quality databases revealed one corrective and preventive action are ongoing monitoring capa-000152: "balloon issues on folysil and silicone prostatic catheters¿.On september we received one used sample.After desinfection sample was observed, according to the description catheter was cut near the valve part and balloon burst.The valve part was missing, so we cannot test functionality of the valve.And due to the balloon burst and the size of inflation channel we cannot investigation this part too.We can confirmed balloon was burst with no missing part.No root cause could be define for this issue.A similar case study was performed based on the same item number, same defect: impossible or difficult deflation over last four year, three similar case were found (b)(4).
Event or Problem Description
According to available information, this device was difficult to deflate.In an attempt to remove the device, the balloon was not deflating despite the catheter being cut in half.The urologist punctured the balloon using a guidewire.No other adverse patient effects were reported.

• 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 (Section G): CMF-SARLAT; 9 avenue edmond rostand; sarlat-la-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 17795978
• Report Number: 9610711-2023-00198
• Device Sequence Number: 2149032
• Product Code: EZL
• UDI-Device Identifier: 03600040126844
• UDI-Public: 3600040126844
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K013174
• 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): 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: AA6106
• Device Lot Number: 8796891_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: 09/21/2023
• Supplement Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2022
• 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
• Patient Sex: Unknown