MAUDE Adverse Event Report: COLOPLAST A/S X-FLOW PROSTATECTOMY CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

Catalog Number AB6118

Device Problem Material Rupture (1546)

Patient Problems Pain (1994); Urinary Retention (2119)

Event Date 10/11/2023

Event Type  malfunction  

Event Description

According to the available information after placement of the catheter, after surgery, the balloon ruptured.A second catheter was placed; however, this balloon also ruptured.The patient experienced pain during removal of each catheter, and also experienced urinary retention.

Manufacturer Narrative

The lot number was reported to be one of the following lots: 8341166, 8765612, 8559602, 9102872 or 8839826.The specific lot involved was unknown.

• Brand Name: X-FLOW PROSTATECTOMY 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: 18132438
• MDR Text Key: 328065654
• Report Number: 9610711-2023-00246
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040143629
• UDI-Public: 3600040143629
• Combination Product (y/n): N
• 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: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AB6118
• Device Lot Number: 8341166_AB61181002
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 12/07/2021
• 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