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

Model Number 789789789

Device Problem Burst Container or Vessel (1074)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 12/25/2023

Event Type  malfunction  

Event Description

According to the available information the patient was catheterized.No clinical consequences.

Event Description

According to the available information the balloon burst on two occasions.There were no clinical consequences but pain and discomfort for the patient.

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.

• 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: 18651241
• MDR Text Key: 334662184
• Report Number: 9610711-2024-00028
• Device Sequence Number: 1
• Product Code: EZL
• 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: 02/06/2024

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
• Device Operator: Health Professional
• Device Model Number: 789789789
• Device Catalogue Number: AB6320
• Device Lot Number: 9240224_AB63201002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2024
• Date Device Manufactured: 06/29/2023
• 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