BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONQUEST PTA BALLOON DILATATION CATHETER

    MDR report key: 1894301 · Received November 4, 2010

    Report

    Report Number
    2020394-2010-00325
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 15, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K014212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE IS NOTHING SEEN IN THE DHR TO INDICATE THAT THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR CORPORATE LOT NUMBER GFUE2779. THE DEVICE WAS RETURNED FOR EVALUATION. THE BALLOON WAS INFLATED WITH AIR UNDER A WARM WATER BATH. UPON INFLATION, BUBBLES WERE OBSERVED EXITING FROM THE CONNECTION BETWEEN THE INFLATION EXTENSION LEG AND THE BIFURCATE. THE COMPLAINT INVESTIGATION IS CONFIRMED FOR A GLUE FILLET LEAK AT THE CONNECTION BETWEEN THE BIFURCATE AND THE INFLATION LEG EXTENSION. IT WAS REPORTED THAT THE BALLOON COULD NOT BE FULLY DEFLATED AND THERE WAS STRONG RESISTANCE REMOVING THE BALLOON CATHETER FROM THE SHEATH; HOWEVER, THE SAMPLE COULD NOT BE TESTED FOR DEFLATION ISSUES BECAUSE FULL INFLATION COULD NOT BE PERFORMED DUE TO THE LEAK. THE INVESTIGATION IS INCONCLUSIVE FOR SHEATH COMPATIBILITY AS THE ORIGINAL SHEATH WAS NOT RETURNED. THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS: DO NOT ADVANCE OR RETRACT THE CATHETER UNLESS THE BALLOON IS FULLY DEFLATED. IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING. APPLYING EXCESSIVE FORCE TO THE CATHETER CAN RESULT IN TIP BREAKAGE OR BALLOON SEPARATION. PRECAUTIONS: IF RESISTANCE IS FELT DURING POST PROCEDURE WITHDRAWAL OF THE CATHETER, IT IS RECOMMENDED TO REMOVE THE BALLOON CATHETER AND GUIDEWIRE/INTRODUCER SHEATH AS A SINGLE UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON WOULD NOT FULLY INFLATE AND A LEAK WAS OBSERVED AT THE BIFURCATE HUB OF THE GUIDEWIRE LUMEN AND INFLATION LUMEN. THE BALLOON COULD NOT BE FULLY DEFLATED AND WAS REMOVED THROUGH THE INTRODUCER SHEATH WITH STRONG RESISTANCE. ANOTHER PTA BALLOON DILATATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONQUEST PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFUE2779

    Patients

    Seq Age Sex Outcome Treatment
    1