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

Catalog Number AA6114

Device Problems Burst Container or Vessel (1074); Material Rupture (1546)

Patient Problem Pain (1994)

Event Date 10/28/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned and it was observed that the balloon end was missing.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, the patient was catheterized on 11 oct 2023 due to urinary retention.On (b)(6) 2023, the patient presented with severe pelvic pain, necessitating removal of the catheter.No fluid had been collected during the attempt to deflate the balloon; upon removal it was identified the balloon had burst.The pain resolved and a new catheter was placed eight hours later.There was possibility of intravesical balloon fragments; no further information was available regarding the missing pieces.

Event Description

Returned device analysis identified the balloon was burst and no missing part.

Manufacturer Narrative

After receiving this complaint, we searched for other complaints and we found none regarding the lot number 9248077.This product was made by our subcontractor.We received a documentary investigation from our subcontractor stating: the probable root cause of this issue was a problem with balloon¿s raw material.A similar case study was done based on same item number, (b)(4), same defect: "balloon burst" from november 2019 to november 2023: 13 similar cases were found.In november we received one used sample.After disinfection we observed the balloon was burst and no missing part.Checking the quality databases revealed one non-conformity in relation to the described defect and a corrective and preventive action are ongoing.A risk management framework evaluation was performed and concluded 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.A clinical assessment was performed and concluded: "based on all the available information, we estimate that the cause of the balloon burst is mainly due to defect product.¿ correction: b1, h1: report changed to malfunction report based on returned analysis.

• 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 (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: 18288087
• MDR Text Key: 329995114
• Report Number: 9610711-2023-00264
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2024

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: AA6114
• Device Lot Number: 9248077_AA61141002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/04/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 66 YR