BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-FLOW PROSTATECTOMY CATHETER

    MDR report key: 21218671 · Received January 23, 2025

    Report

    Report Number
    9610711-2025-00017
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Date of Event
    December 26, 2024
    Report Date
    March 21, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040144183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE DIDN'T FIND OTHER COMPLAINTS REGARDING THE LOT NUMBER 9143103 ON THE SAME DEFECT.

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE DIDN'T FIND OTHER COMPLAINT REGARDING THE LOT NUMBER 9143103 ON THE SAME DEFECT. BALLOONS COMPONENTS WERE MADE FROM 2 DIFFERENT BATCHES OF VS014150 (REFERENCE) AND THE LOT NUMBER WERE 8807787 & 8789748 IT WAS PREPARED FROM A MIX OF RAW MATERIALS SAA339 LOT NUMBER 2203150048 & 2209060067 & 2202080081 AND SA7117 LOT NUMBER 2205240137. THESE LOTS NUMBER WERE ANALYSED AT OUR QA PRODUCTION LABORATORIES AND WERE CONFORMED. WE RECEIVED ONE USED SAMPLE WITH BALLOON BURST. BALLOON WAS BURST, AND ONE PART OF THE BALLOON HAS COMPLETELY DETACHED FROM THE CATHETER DURING DISINFECTION. IN THIS CONDITION IT WAS DIFFICULT TO CHECK THE INTEGRITY OF THE BALLOON. BURSTING ISSUE OF SILICONE BALLOON IS KNOWN BUT ACCORDING TO THE AVAILABLE INFORMATION WE CANNOT CONCLUDE ON A SPECIFIC ROOT CAUSE IN THIS CASE. QUALITY DATABASE WAS CHECKED AND REVEALED A CORRECTIVE AND PREVENTIVE ACTION: CAPA-000152. "BALLOON ISSUES ON FOLYSIL AND SILICONE PROSTATIC CATHETERS" WAS OPENED AND MONTHLY MONITORING. NO CORRECTIVE ACTION WILL BE IMPLEMENTED AS OUR TREND IS NOT INCREASING AND THE THRESHOLD IS NOT EXCEEDED. A SIMILAR CASE STUDY WAS PERFORMED BASED ON PRODUCT PROSTATIC CATHETER, DEFECT BALLOON BURST FROM (B)(6) 2021 TO (B)(6) 2025: 121 SIMILAR CASES WERE FOUND. THE EVALUATION HAS SHOWED THAT RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE IN THE STATE OF ART LEVEL. BASED ON THIS, WE CAN CONCLUDE 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. IT IS CONCLUDED THAT THE RISKS IDENTIFIED ARE STILL ACCEPTABLE AND CONSIDERED AS SAFE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, ON (B)(6), A BLADDER CATHETER WAS INSERTED AT THE END OF THE DAY. THE MORNING OF (B)(6), DURING THE NURSE'S ROUNDS, THE NURSE NOTICED URINE IN THE PATIENT'S BED. SHE FOUND THE CATHETER EXTERIORIZED AND THE BALLOON RUPTURED. THERE WERE NO CONSEQUENCES FOR THE PATIENT. THIS WAS AN ISOLATED INCIDENT.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, ON (B)(6), A BLADDER CATHETER WAS INSERTED AT THE END OF THE DAY. THE MORNING OF (B)(6), DURING THE NURSE'S ROUNDS, THE NURSE NOTICED URINE IN THE PATIENT'S BED. SHE FOUND THE CATHETER EXTERIORIZED AND THE BALLOON RUPTURED. THERE WERE NO CONSEQUENCES FOR THE PATIENT. THIS WAS AN ISOLATED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525060 X-FLOW PROSTATECTOMY CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9143103_AB63181002 03600040144183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown