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

Catalog Number AB6318

Device Problems Burst Container or Vessel (1074); Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2023

Event Type  malfunction  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to available information, this device had a balloon crack.The patient needed to be catheterized again.No other adverse patient effects were reported.

Manufacturer Narrative

After receiving this complaint, we searched for other complaint and we didn¿t find other complaint on the lot number 9282506.Checking the quality databases revealed one non-conformity in relation to the described defect and a corrective and preventive action: - nc (b)(4): "pb ballons (bulles + agglutinés)" opened in 16 january 2023.For this nc, the used of clumped balloons should be responsible of some weakness on the balloon and being responsible of bursting.- monitoring capa-000152: "balloon issues on folysil and silicone prostatic catheters".The trending for balloon bursting is specifically monitored.On 14th december, we received documentary investigation by our subcontractor which mentionned known issue with raw material balloon, a similar case study based on item number ab63xx, defect balloon burst, over last four year: 55 similar case were found.

Event Description

According to available information, this device had a balloon crack.The patient needed to be catheterized again.No other adverse patient effects were reported.

• 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: 17917559
• MDR Text Key: 325458290
• Report Number: 9610711-2023-00219
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040144183
• UDI-Public: 3600040144183
• 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,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: AB6318
• Device Lot Number: 9282506_AB63181002
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2023
• 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