BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWP CATHETER

    MDR report key: 7968615 · Received October 16, 2018

    Report

    Report Number
    1220452-2018-00121
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Date of Event
    April 17, 2018
    Report Date
    October 16, 2018
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DQO
    PMA / PMN Number
    K884065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS SUMMARY: THE BALLOON WAS RECEIVED SOILED IN MEDIA AND DRIED BLOOD. THE BALLOON IS SEVERELY TORN. PROXIMAL AND DISTAL SEALS REMAINED INTACT. THE INFLATION HOLE WAS FILLED WITH DRIED MEDIA AND BLOOD. NO OTHER DAMAGE NOTED TO THE INFLATION OR FLUSHING LEGS. THE SYRINGE IS FUNCTIONAL AND WITHOUT DEFECT. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OR DAMAGE TO THE RETURNED DEVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS INTENDED TO USE A PWP BALLOON CATHETER TO MEASURE VALVE GRADIENTS. NO DAMAGE WAS NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU, INSPECTED AND PREPPED PER IFU ALL WITH NO ISSUES NOTED. IT IS REPORTED THAT THE BALLOON WOULD NOT INFLATE PRIOR TO USE. THE PROVIDED SYRINGE WAS BEING USED. THE SYRINGE IS CONNECTED DIRECTLY TO THE INFLATION LEG. IT WAS REPLACED WITH ANOTHER PWP THAT WORKED SUCCESSFULLY. ANALYSIS OF THE RETURNED DEVICE SHOWED THAT THE DEVICE WAS SOILED WITH MEDIA AND BLOOD AND HAD A SEVERE RUPTURE. IT WAS THEN CONFIRMED BY THE ACCOUNT THAT THE DEVICE HAD BEEN ATTEMPTED TO BE USED IN THE PATIENT. DURING ATTEMPTED INFLATION THE BALLOON BURST IN VIVO. THE DEVICE WAS THEN REMOVED FROM THE PATIENT AND THE PROCEDURE SUCCESSFULLY COMPLETED USING ANOTHER PWP CATHETER. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812721 PWP CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1