BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYD

    MDR report key: 1818346 · Received August 20, 2010

    Report

    Report Number
    2024168-2010-01716
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES-P.R.
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE #1: THE RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER (PART 1008193-15, LOT 9060851) INDICATED IS BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBER. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    DEVICE ISSUE: WIRE TIP DETACHMENT. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: REQUIRED INTERVENTION. IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE IN THE CELIAC ARTERY, AFTER INFLATING AND DEFLATING THE VIATRAC BALLOON, BLOOD WAS NOTED IN THE INDEFLATOR. THE VIATRAC CATHETER COULD NOT BE REMOVED FROM THE BHW WIRE; IT WAS STUCK. IN ATTEMPT TO "UNSTICK" THE CATHETER, THE CATHETER WAS ADVANCED ON THE WIRE, BUT THE WIRE BROKE APPROXIMATELY 20 CM FROM ITS DISTAL TIP AND REMAINED IN THE CATHETER. THE PROXIMAL END OF THE WIRE WAS REMOVED FROM THE ANATOMY. AS THE CATHETER WITH THE DISTAL TIP OF THE WIRE WAS PULLED TO REMOVE IT FROM THE ANATOMY, THE CATHETER BROKE INTO TWO SEPARATE PIECES APPROXIMATELY 20 CM FROM THE DISTAL END. THE PROXIMAL END OF THE CATHETER WAS REMOVED FOR THE ANATOMY. THE DISTAL END OF THE CATHETER WITH THE DISTAL END OF THE WIRE INSIDE WAS SNARED AND REMOVED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYD DQX ABBOTT VASCULAR-CARDIAC THERAPIES-P.R. NA 0051281

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER| (PART 1008193-15, LOT 9060851)