BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 1686406 · Received May 13, 2010

    Report

    Report Number
    2134265-2010-02384
    Event Type
    Death
    Date Received
    May 13, 2010
    Date of Event
    April 9, 2010
    Report Date
    April 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (6). DEVICE EVALUATION 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)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION BY MANUFACTURER: THE VISUAL INSPECTION REVEALS THE WIRE KINKED AT APPROXIMATELY 10 CM MEASURING FROM THE J TIP. THE WIRE HAS A BEND BEGINNING APPROXIMATELY 23 CM THROUGH 33 CM MEASURING FROM THE J TIP. SCRAPED COATING WAS NOTED ALONG THE LENGTH OF THE WIRE. THE MAXIMUM OUTSIDE DIAMETER OF THE WIRE WAS MEASURED AND WITHIN SPECIFICATIONS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION. (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST AN ANGIOGRAM PROCEDURE, A PATIENT DEATH OCCURRED. THE PATIENT PRESENTED WITH ANGINA. THE LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE AMPLATZ SUPER STIFF J TIP GUIDE WIRE WAS USED DURING THE ANGIOGRAM. POST THE PROCEDURE, THE PATIENT EXPERIENCED A VASOSPASM AND DIED. CAUSE OF DEATH WAS REPORTED AS AN MI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST AN ANGIOGRAM PROCEDURE, A PATIENT DEATH OCCURRED. THE PATIENT PRESENTED WITH ANGINA. THE LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE AMPLATZ SUPER STIFF J TIP GUIDE WIRE WAS USED DURING THE ANGIOGRAM. POST THE PROCEDURE, THE PATIENT EXPERIENCED A VASOSPASM AND DIED. CAUSE OF DEATH WAS REPORTED AS AN MI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MIAMI M001465021 13114041

    Patients

    Seq Age Sex Outcome Treatment
    1 Death