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	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	12/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information the patient was catheterized.No clinical consequences.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and found none on the lot 9240224.The probable root cause of this issue was a problem with balloon¿s raw material.Checking the quality databases revealed this type of defect is known and closely /specifically monitored.A similar case study was performed based on same item number and same defect [balloon burst] over last four years, 57 similar cases were found.A risk management framework evaluation was performed and concluded 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.Correction: b5: event description.
Event or Problem Description
According to the available information the balloon burst on two occasions.There were no clinical consequences but pain and discomfort for the patient.

• 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: 18651248
• Report Number: 9610711-2024-00029
• Device Sequence Number: 7112015
• Product Code: EZL
• UDI-Device Identifier: 03600040144312
• UDI-Public: 3600040144312
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

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
• Operator of Device: Health Professional
• Device Model Number: 789789789
• Device Catalogue Number: AB6320
• Device Lot Number: 9240224_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: 02/06/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2023
• 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
• Patient Sex: Unknown