BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONQUEST PTA BALLOON DILATATION CATHETER

    MDR report key: 4780941 · Received April 15, 2015

    Report

    Report Number
    2020394-2015-00376
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    February 4, 2015
    Report Date
    February 5, 2015
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K083657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FURTHER CLINICA REVIEW WAS PERFORMED AND IDENTIFIED THIS EVENT TO BE MDR REPORTABLE PURSUANT TO 21 CFR PART 803. THE LOT NUMBER HAS BEEN PROVIDED AND THE LOT DEVICE HISTORY RECORDS HAVE BEEN REVIEWED. THE LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED FOR THIS LOT NUMBER AND ISSUE TO DATE. THE DEVICE WAS RETURNED. THE INVESTIGATION IS CONFIRMED FOR INFLATION ISSUES AS THE BALLOON WAS UNABLE TO INFLATE DUE TO THE GLUE BULLET BEING LODGED IN THE OUTER CATHETER SHAFT AND BLOCKING THE INFLATION/DEFLATION PORTS. THE INVESTIGATION IS CONFIRMED FOR A PRODUCT QUALITY ISSUE, AS THE GLUE BULLET WAS FOUND TO BE LODGED WITHIN THE OUTER CATHETER SHAFT. THE EVALUATION FOUND THE GLUE BULLET WAS LODGED WITHIN THE CATHETER SHAFT, PARTIALLY BLOCKING THE INFLATION/DEFLATION PORTS. THE OD OF THE GLUE BULLET DID NOT MEET THE MINIMUM SPECIFICATIONS. THE ROOT CAUSE FOR THE IMPROPERLY FORMED GLUE BULLET IS MANUFACTURING RELATED. THE ROOT CAUSE FOR THE INFLATION ISSUES IS LIKELY RELATED TO THE GLUE BULLET BECOMING LODGED WITHIN THE CATHETER SHAFT. THE CONQUEST INSTRUCTIONS FOR USE (IFU) PROVIDES GENERAL INSTRUCTIONS FOR USE OF THE DEVICE, AS WELL AS WARNINGS, PRECAUTIONS, AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. 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, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON WOULD NOT INFLATE BEYOND 15 ATM IN A SUBCLAVIAN IN STENT RESTENOSIS. THE DEVICE WAS DEFLATED AND RETRACTED THROUGH THE SHEATH WITHOUT DIFFICULTY. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252921 CONQUEST PTA BALLOON DILATATION CATHETER DQY DQY BARD PERIPHERAL VASCULAR, INC. REYB2251

    Patients

    Seq Age Sex Outcome Treatment
    1