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

Model Number AB63181002

Device Problem Burst Container or Vessel (1074)

Patient Problem Hematuria (2558)

Event Date 09/14/2022

Event Type  malfunction  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to available information, this device required replacement due to a balloon burst.Three devices burst and fell out after placement and balloon test.One device had its balloon inflated with 45 ml of sterile water.Another balloon burst during the test with 20 ml of sterile water.The patient presented with hematuria after repeated attempts at placement.A device was successfully placed without any problem.

• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 15669200
• MDR Text Key: 306887465
• Report Number: 9610711-2022-00086
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040144183
• UDI-Public: 03600040144183
• 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: 10/25/2022

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: AB63181002
• Device Catalogue Number: AB6318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/25/2022
• 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