BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONQUEST PTA BALLOON DILATATION CATHETER

    MDR report key: 4781416 · Received April 15, 2015

    Report

    Report Number
    2020394-2015-00355
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    December 13, 2013
    Report Date
    December 20, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K083657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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. THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THE LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. THE INVESTIGATION IS CONFIRMED, AS A LEAK WAS OBSERVED IN THE GLUE FILLET OF THE INFLATION HUB. THE ROOT CAUSE IS MANUFACTURING RELATED AS THE GLUE FILLET FELT TACKY AND SOFT TO THE TOUCH, WHICH INDICATES THAT THE GLUE HAD NOT FULLY CURED. OPERATOR AWARENESS TRAINING REGARDING THE GLUE FILLET PROCESS WAS PERFORMED. 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 DILATATION CATHETER LEAKED FROM THE HUB OF THE INFLATION LUMEN DURING AN INITIAL INFLATION ATTEMPT. THERE WAS NO REPORTED RETRACTION ISSUES. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252705 CONQUEST PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. REWE1257

    Patients

    Seq Age Sex Outcome Treatment
    1