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

Model Number	789789789
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hematuria (2558)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
A picture of the device was received and we can observe catheter with one way broken.This way may be broken by a sharp object or by an excess of force on the medical device.Checking the quality database revealed no anomaly in relation to the described defect.A similar case study was performed based on same item number, same defect [broken] over the last four years: 2 similar case were found.A risk management file evaluation was done and concludes that residual risks are adequately controlled and reduced as far as possible, and the residual risks associated with the use of the product are acceptable when weighed against the benefits to the patient/user.It is concluded that the risks identified are still acceptable and considered as safe.

• Brand Name: X-FLOW PROSTATECTOMY CATHETER
• Common Device Name: 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
• Report Number: 9610711-2023-00290
• Device Sequence Number: 14121516
• Product Code: EZL
• UDI-Device Identifier: 03600040143711
• UDI-Public: 3600040143711
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 789789789
• Device Catalogue Number: AB6320
• Device Lot Number: 9341187_AB63201002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown