BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETIX PTCA GUIDEWIRE

    MDR report key: 2063447 · Received April 19, 2011

    Report

    Report Number
    2134265-2011-01350
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: 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

    IT WAS REPORTED THAT DURING A CORONARY ARTERY TREATMENT PROCEDURE A DISSECTION OCCURRED. THE LESION WAS LOCATED IN THE PROXIMAL CIRCUMFLEX. THE DR. WAS ADVANCING THE WIRE THROUGH A "CRUDY" TORTUOUS ARTERY. ONCE THE ARTERY HIT 90 DEGREES THE WIRE DID NOT FOLLOW THE ARTERY AND WENT INTO THE SUB INTIMAL. ONCE THIS HAPPENED THE PHYSICIAN REMOVED THE WIRE AND PROCEEDED TO USE A NON BSC WIRE TO COMPLETE THE PROCEDURE. THE PATIENT CONDITION IS STABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE WIRE PIERCED THE INTIMA WALL BUT DID NOT DISSECT THE ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETIX PTCA GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H74939122012 0013515918

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Other WHISPER GUIDE WIRE