BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIPWIRE HYDROPHILIC GUIDE WIRE

    MDR report key: 1871437 · Received October 15, 2010

    Report

    Report Number
    2134265-2010-04547
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K000011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UF/IMPORTER REPORT (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    FACILITY MEDWATCH (B)(4). IT WAS REPORTED VIA A FACILITY MEDWATCH THAT DURING A LEFT HEART CATHETERIZATION TREATMENT PROCEDURE, A PORTION OF THE GUIDE WIRE DETACHED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. ANGIOGRAPHY WAS PERFORMED REVEALING A 30% STENOSIS IN THE OSTIAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND A 30% STENOSIS IN THE MID DOMINANT RIGHT CORONARY ARTERY (RCA). THE LEFT VENTRICULOGRAM DEMONSTRATED NORMAL SYSTOLIC CONTRACTILITY WITH A CALCULATED EJECTION FRACTION OF 70%. AT AN UNSPECIFIED TIME DURING THE LEFT HEART CATHETERIZATION, 5CM OF THE 035/180 ZIPWIRE HYDROPHILIC GUIDE WIRE DETACHED IN THE RIGHT ARTERIAL TREE. THE LEFT LIMB OF A PREVIOUSLY PLACED Y-GRAFT GOING INTO THE LEFT ARTERY WAS ACCESSED PERCUTANEOUSLY ON THE LEFT SIDE UTILIZING AN 18 GAUGE NEEDLE. A NON-BSC WIRE WAS ADVANCED INTO THE ABDOMINAL AORTA. A 6FR INTRODUCER WAS PLACED AND A PIGTAIL CATHETER WAS ADVANCED TO COMPLETE AN ABDOMINAL AORTAGRAM WHICH REVEALED A CHRONICALLY OCCLUDED RIGHT SUPERFICIAL FEMORAL ARTERY AND THE WIRE FRAGMENT IN A COLLATERAL BRANCH OF THE WIDELY PATENT RIGHT DEEP FEMORAL ARTERY. THE 6FR INTRODUCER WAS EXCHANGED FOR A 6FR UP-AND-OVER CROSSOVER CATHETER WHICH WAS PLACED IN THE DISTAL SEGMENT OF THE RIGHT LIMB OF THE Y-GRAFT. A NON-BSC CATHETER AND WIRE WERE UTILIZED TO NEGOTIATE THROUGH THE Y-GRAFT ANASTOMOSIS INTO THE DEEP FEMORAL ARTERY AND THEN INTO THE BRANCH WHERE THE WIRE WAS LOCATED. THE CATHETER WAS THEN REMOVED AND A SNARE WAS UTILIZED TO RETRIEVE THE WIRE FRAGMENT SUCCESSFULLY. THE CARDIAC CATHETERIZATION PROCEDURE WAS THEN CONTINUED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIPWIRE HYDROPHILIC GUIDE WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE M00146308B1 0001421439

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention