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

Model Number AB61241002

Device Problem Material Rupture (1546)

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

Event Type  malfunction  

Manufacturer Narrative

Visual analysis of the returned device revealed a balloon burst.The balloon burst issue is known and monitored on a monthly basis.The possible cause is a weakness area in the silicone material of the balloon.In parallel, a specific trend is monitored regarding the silicone balloon issue.Medical device expiration date: march 2021.Device manufacture date: march 2016.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

According to the available information, the catheter was indwelled following a transurethral resection (turp).The catheter fell off and a balloon burst was identified.It is unknown how long the catheter was in place before it burst.

• 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: 10748060
• MDR Text Key: 213459687
• Report Number: 9610711-2020-00055
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040143896
• UDI-Public: 03600040143896
• 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,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/27/2020

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 Expiration Date: 03/01/2021
• Device Model Number: AB61241002
• Device Catalogue Number: AB6124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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