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

Catalog Number AA6120

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2023

Event Type  malfunction  

Event Description

According to the available information the balloon was found torn.A new catheter was inserted successfully.No adverse patient events were reported.

Manufacturer Narrative

After receiving this complaint, we searched for other complaints and we found one other complaint regarding the lot number 9226766 but not on the same defect for a deflated balloon ((b)(4)).Checking the quality databases revealed one non-conformity in relation to the described defect and a corrective and preventive action: nc (b)(4): "pb balloons (bulles + agglutinés)" opened in 16 january 2023.For this nc, the used of clumped balloons should be responsible of some weakness on the balloon and being responsible of bursting.Monitoring capa-000152: "balloon issues on folysil and silicone prostatic catheters".The trending for balloon bursting on folysil is specifically monitored.A similar case study was performed based on same item number, same defect over last four year, 3 similar cases were found ((b)(4)).On 4th april, we received 5 sealed samples and 4 used samples.One of the 4 unsealed samples was burst without missing part.After decontamination of unsealed samples three of the samples where inflated with 15ml of water and no burst was observed.The five sealed samples where tested also by inflating them with 15ml of water and were conformed (see sample's investigation).On 6th june, we received the documentary investigation report from our subcontractor concluding that:" the probably root cause of this issue was a problem with balloon¿s raw material".

Event Description

According to the available information the balloon was found torn.A new catheter was inserted successfully.No adverse patient events were reported.

• Brand Name: FOLYSIL SILICONE CATHETER
• Type of Device: 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: 19155741
• MDR Text Key: 341005465
• Report Number: 9610711-2024-00092
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K233411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/30/2024

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 Operator: Health Professional
• Device Catalogue Number: AA6120
• Device Lot Number: 9226766_AA61201002
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1