BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACCESS PTA DILATATION CATHETER

    MDR report key: 8824310 · Received July 24, 2019

    Report

    Report Number
    2020394-2019-01840
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Report Date
    October 22, 2019
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    UDI-DI
    00801741121357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE LOT NUMBER FOR THE MALFUNCTION WAS PROVIDED AND A LOT HISTORY REVIEW WILL BE PERFORMED. THE DEVICE HAS BEEN RETURNED FOR EVALUATION; THE EVALUATION IDENTIFIED MATERIAL RUPTURE, BALLOON DETACHMENT, RETRACTION ISSUES, AND DISLODGEMENT. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE. H10: B5: EVENT, G4: PMA/510K. H11: G1: MFR SITE, H6 (DEVICE CODE 2923). H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL: VA8094 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE, DETACHMENT, RETRACTION PROBLEM, AND DISLODGEMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT¿S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE MALFUNCTION WAS PROVIDED AND A LOT HISTORY REVIEW WILL BE PERFORMED. THE DEVICE HAS BEEN RETURNED FOR EVALUATION; THE EVALUATION IDENTIFIED MATERIAL RUPTURE AND MISSING BALLOON SEGMENTS. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL VA8094 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT¿S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616401 VACCESS PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. VA8094 93QD0070 00801741121357

    Patients

    Seq Age Sex Outcome Treatment
    1