BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONQUEST PTA BALLOON DILATATION CATHETER

    MDR report key: 3231829 · Received July 12, 2013

    Report

    Report Number
    2020394-2013-00202
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K083657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MFG REVIEW WAS PERFORMED AND THE LOT MET ALL RELEASE CRITERIA. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER AND FOR THESE FAILURE MODE. THE INVESTIGATION IS INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED. REPORTEDLY, SOME OF THE INFLATIONS WERE REPORTED TO BE IN THE STENT WHEN A PINHOLE RUPTURED WAS OBSERVED. THERE MAY HAVE BEEN AN INTERACTION BETWEEN THE BALLOON AND THE STENT WHICH CONTRIBUTED TO THE REPORTED EVENT, HOWEVER, THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFO. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES; WARNINGS: WHEN THE CATHETER IS EXPOSED TO THE VASCULAR SYSTEM, IT SHOULD BE MANIPULATED WHILE UNDER HIGH-QUALITY FLUOROSCOPIC OBSERVATION. 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. PRECAUTION: 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. POTENTIAL ADVERSE REACTIONS: ADD'L INTERVENTION USE OF THE CONQUEST PTA DILATATION CATHETER: WHILE MAINTAINING NEGATIVE PRESSURE AND THE POSITION OF THE GUIDEWIRE, WITHDRAW THE DEFLATED DILATATION COUNTERCLOCKWISE MOTION MAY BE USED TO HELP FACILITATE CATHETER REMOVAL THROUGH THE INTRODUCER SHEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON RUPTURED AFTER SEVERAL INFLATIONS IN A FISTULA AND WITHIN A STENT IN THE CEPHALIC ARCH, AND THE BALLOON WAS SUBSEQUENTLY UNABLE TO BE WITHDRAWN THROUGH THE INTRODUCER SHEATH. THE SHEATH WAS EXCHANGED FOR A LARGER SHEATH AND DURING REMOVAL OF THE CATHETER, THE BALLOON DETACHED IN THE CEPHALIC VEIN. SURGICAL INTERVENTION WAS REQUIRED TO REMOVED THE DETACHED BALLOON FROM THE VESSEL. THE PT WAS REPORTED TO BE DOING WELL AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323681 CONQUEST PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. REXD0562

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention