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

Catalog Number	AA7114
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information the patient pulled out an indwelling catheter, and was found to be missing the balloon, which had been cut off.The balloon was not found in the room or the patient after endoscopy for cystoscopy was performed.The patient was re-catheterized.
Event or Problem Description
According to the available information the patient pulled out an indwelling catheter, and the catheter was found to be missing the balloon, which had been cut off.The balloon was not found in the room.The patient was referred to endoscopy for cystoscopy and the patient was re-catheterized.
Additional Manufacturer Narrative
Estimated date after receiving this complaint, we searched for other complaints and we found none regarding the lot number 9253806.After disinfection of the used sample, it was observed that balloon was burst.We received a documentary investigation from our tunisian subcontractor: the root cause was probably due to a defect in the balloon¿s raw material.Checking the quality databases revealed this type of defect is known and closely monitored a similar case study was performed based on same item number and same defect [balloon burst] over the last four years; no similar cases were found.A risk assessment was performed and concluded that the 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.Corrections: b1/2: report type corrected from malfunction to serious injury.B5: incident description.H1: type of report correct from malfunction to serious injury.

• Brand Name: FOLYSIL SILICONE CATHETER - LONG-TERM
• 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: 18149935
• Report Number: 9610711-2023-00248
• Device Sequence Number: 6613561
• Product Code: EZL
• UDI-Device Identifier: 03600040127360
• UDI-Public: 3600040127360
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/06/2024

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: AA7114
• 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: 11/16/2023
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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