MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number AA61161002

Device Problem Burst Container or Vessel (1074)

Patient Problems Discomfort (2330); Urinary Incontinence (4572)

Event Date 05/20/2021

Event Type  malfunction  

Manufacturer Narrative

Lot number: 7359616.Two catheters were received for analysis.Visual examination revealed balloon bursts.Balloon bursts are a known issue, monitored on a monthly basis.The possible cause may be a weakness area in the silicone material of the balloon.See manufacturer report numbers 9610711-2021-00050 & 9610711-2021-00051 regarding the other two catheters with reported balloon bursts.

Event Description

According to the available information, the balloon was inflated with 15 milliliters.A few hours later the balloon burst and the catheter slipped off.A new catheter was placed, but the same issue occurred, so a third catheter was placed.The same issue occurred a third time.There was no clinical consequence for the patient other than discomfort and leaks.The physician used a foley catheter from another manufacturer for this patient.

• Brand Name: FOLYSIL CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12257879
• MDR Text Key: 264469265
• Report Number: 9610711-2021-00049
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040127490
• UDI-Public: 03600040127490
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2021

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: Lay User/Patient
• Device Model Number: AA61161002
• Device Catalogue Number: AA6116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 08/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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