MAUDE Adverse Event Report: COLOPLAST A/S X-FLOW CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number	AB61181002
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
According to available information, this device required replacement due to a balloon burst.No other adverse patient effects were reported.
Additional Manufacturer Narrative
The review of the complaint history database, revealed no trends for the lot number 8361012.The product reference ab61181002 lot number 8361012 has been manufactured for (b)(4) pieces in february 2023.The expiry date is december 2026.Checking the quality databases revealed one non-conformity tw822426 opened on january 2023 and a corrective and preventive action is ongoing tw470775 "balloon bursting trending for folysil and silicone prostatic catheters." on 21th february, we received one used sample.Visually we saw balloon was burst, sample was sent to our subcontractor for investigation.On 21th april we received subcontractor's investigation: "the probably root cause of the balloon burst was defect of raw material a non-conformity was already opened about this topic.For this issue capa tw470775 and nc tw822426 covers the lot number 8163612 made in december 2021.

• Brand Name: X-FLOW CATHETER
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16440922
• Report Number: 9610711-2023-00025
• Device Sequence Number: 16925571
• Product Code: EZL
• UDI-Device Identifier: 03600040143629
• UDI-Public: 03600040143629
• Combination Product (Y/N): N
• PMA/510(K) Number: K013172
• 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): 05/17/2023

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: AB61181002
• Device Catalogue Number: AB6118
• Device Lot Number: 8361012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 02/25/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• 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