BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IQ GUIDE WIRE

    MDR report key: 1150164 · Received August 28, 2008

    Report

    Report Number
    2134265-2008-02471
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    August 2, 2008
    Report Date
    August 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    k040140
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 PROD FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION / STENTING TREATMENT PROCEDURE A WIRE FRACTURE OCCURRED AND THE PT WAS SENT FOR SURGERY. THE PT PRESENTED WITH RIGHT ARM PAIN AND SEVERE HYPERTENSION, EXPERIENCING ACUTE CORONARY SYNDROME. THE PT WAS SENT FOR EMERGENT LEFT HEART CATHETERIZATION AND ANGIOGRAPHY. ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. ANGIOGRAPHY REVEALED A 99% STENOSIS AT THE OSTIUM OF THE 1ST MARGINAL BRANCH. THE 0.14 IQ GUIDE WIRE WAS ADVANCED AND PLACED DISTALLY IN THE MARGINAL BRANCH. ANGIOPLASTY WAS PERFORMED WITH A 2.0 X 9 MM MAVERICK BALLOON. A 2.0 X 12 MM NON-BSC STENT WAS IMPLANTED. "REDUNDANT LOOP GOT CAUGHT UNDER THE STENT AND WITH RETRACTION OF THE GUIDE WIRE PART OF IT SHEARED OFF." FLUOROSCOPY REVEALED THE GUIDE WIRE EXTENDED INTO THE AORTIC ROOT AND DESCENDING AORTA. DIFFERENT SIZED SNARES WERE USED IN ATTEMPTS TO RETRIEVE THE GUIDE WIRE, HOWEVER A LONG PORTION OF THE GUIDE WIRE REMAINED IN THE PT. DURING THE EVENT, THE PT BECAME HYPOTENSIVE, DIAPHORETIC AND BRADYCARDIC. ATROPINE AND DOPAMINE WERE ADMINISTERED AND AN INTRA-AORTIC BALLOON PUMP WAS PLACED. THE PT WAS GIVEN HEPARIN AND ZOFRAN DURING THE PROCEDURE. CARDIOTHORACIC SURGERY WAS NOTIFIED FOR RETRIEVAL OF GUIDE WIRE AND MULTI-VESSEL CABG AND THE PT WAS TRANSFERRED TO ANOTHER FACILITY FOR SURGERY AND THE GUIDE WIRE WAS RETRIEVED. NO FURTHER PT COMPLICATIONS WERE REPORTED. PT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IQ GUIDE WIRE DQX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC 185 CM, STRAIGHT *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 2.0 X 12 MM MINIVISION STENT