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

Catalog Number	AB6324
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Pain (1994)
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 balloon burst.The patient reported pain, the device was found in the bed with a burst balloon.No other adverse patient effects were reported.
Additional Manufacturer Narrative
Checking the quality databases revealed one non-conformity in relation to the described defect and a corrective and preventive action are ongoing.On (b)(6) we received one sealed sample.Balloon was inflated with 40ml, no leakage no bursting were observed.An issue concerning raw material¿s balloon was observed and non-conformity was opened.The probably root cause of this issue was due to the balloon's raw material.To our knowledge/understanding of the event, the x-flow prostatic catheter ref.(b)(4)has been inserted in a patient following trans-urethral resection of the prostate (turp) for bladder irrigation/lavage.Six days later, the catheter has withdrawn from the patient due to balloon spontaneous deflation (balloon pierced) and requiring 2 successive catheter replacements (the incident occurred twice).Additionally, a similar incident has occurred in another patient as mentioned by the complainant.-such incident of balloon spontaneous deflation due to balloon pierced causing severe pain to the operated patient (the patient also presented micro-calculi) and requiring re-intervention for 2 successive replacements is estimated severity 3.-more generally, such incident of balloon pierced causing deflation represents clinical risk of blood clots formation and urinary tract infection as mentioned by the complainant, which is severity 3.Similar case study was performed based on over last four years; same item number and defect: balloon burst.No similar case was found.

• 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: 17409923
• Report Number: 9610711-2023-00148
• Device Sequence Number: 5900522
• Product Code: EZL
• UDI-Device Identifier: 03600040144572
• UDI-Public: 3600040144572
• 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): 12/22/2023

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
• Device Catalogue Number: AB6324
• Device Lot Number: 8923570_AB63241002
• 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: 07/27/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male