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

Model Number 789789789

Device Problem Fracture (1260)

Patient Problem Hematuria (2558)

Event Date 11/29/2023

Event Type  Injury  

Event Description

According to the available information a quadriplegic patient was surveyed regarding catheter changes.On 26/11 the catheter was changed.Since that change hemorrhage on affected arterioles, hypotension plus deglobulation, and bladder lavage was observed.On 29/11 at 9a.M., a change of the vesical lavage bag resulted in the lavage line spontaneously rupturing, preventing insertion of tubing and necessitating insertion of a new 3-way indwelling catheter.The patient experienced reactivation of hematuria.The catheter becomes regularly blocked, deglobulation and hypotension necessitate transfusion of 2 units of pgr and transfer of the patient to intensive care with paramedics at the patient¿s bedside for 3 hours.

• 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: 18409484
• MDR Text Key: 331499787
• Report Number: 9610711-2023-00290
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040143711
• UDI-Public: 3600040143711
• 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: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 789789789
• Device Catalogue Number: AB6320
• Device Lot Number: 9341187_AB63201002
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 08/30/2023
• 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
• Patient Outcome(s): Required Intervention