BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIVAL PTA BALLOON DILATATION CATHETER

    MDR report key: 4780942 · Received April 15, 2015

    Report

    Report Number
    2020394-2015-00384
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    January 23, 2015
    Report Date
    February 6, 2015
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K052149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FURTHER CLINICAL REVIEW WAS PERFORMED AND IDENTIFIED THIS EVENT TO BE MDR REPORTABLE PURSUANT TO 21 CFR PART 803. A COMPLETE MANUFACTURING REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. THE DEVICE WAS RETURNED. THE INVESTIGATION IS CONFIRMED FOR A PARTIAL CIRCUMFERENTIAL RUPTURE. THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT IS UNKNOWN IF PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE EVENT. THE RIVAL PTA BALLOON INSTRUCTIONS FOR USE (IFU) PROVIDE GENERAL INSTRUCTIONS FOR USE OF THE DEVICE, AS WELL AS WARNINGS, PRECAUTIONS, AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. A-D: THE INFORMATION PROVIDED BY BARD 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, PRIDUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON RUPTURED (ATM UNK). THERE WAS NO REPORTED RETRACTION DIFFICULTY THROUGH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252906 RIVAL PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1