MAUDE Adverse Event Report: COLOPLAST A/S X-FLOW CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number AB63221002

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

Visual observation of the returned device revealed a balloon burst.A possible root cause was a weak area in the silicone material of the balloon.No other complaints were identified involving this lot number.

Event Description

According to the available information, when 50 milliliters of water was injected, the balloon burst.A new catheter was used.

• Brand Name: X-FLOW 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: usauv autumn valentine ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 11124629
• MDR Text Key: 225340292
• Report Number: 9610711-2021-00006
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040144442
• UDI-Public: 03600040144442
• Combination Product (y/n): N
• PMA/PMN Number: K013172
• 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
• Report Date: 01/06/2021

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: Health Professional
• Device Model Number: AB63221002
• Device Catalogue Number: AB6322
• Device Lot Number: 7129999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1