BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRE GUIDEWIRE

    MDR report key: 7439311 · Received April 18, 2018

    Report

    Report Number
    2134812-2018-00026
    Event Type
    Injury
    Date Received
    April 18, 2018
    Date of Event
    March 19, 2018
    Report Date
    March 20, 2018
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    DQX
    UDI-DI
    M20673861
    PMA / PMN Number
    K163444
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING RECORD REVIEW WAS COMPLETED AND ZERO NONCONFORMANCES WERE FOUND. THE RETURNED PRODUCT EVALUATION CONFIRMED THE DAMAGE TO THE SPECTRE WIRE. THE CORE WIRE WAS BROKEN AND ABOUT 1.5 CM WERE MISSING. THE COIL WAS UNRAVELED AND BROKEN. THE SPECTRE IFU WARNS; "NEVER ADVANCE OR WITHDRAW AN INTRAVASCULAR DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THE RESISTANCE IS DETERMINED BY FLUOROSCOPY. MOVEMENT OF THE GUIDEWIRE AGAINST RESISTANCE MAY RESULT IN SEPARATION OF THE GUIDEWIRE TIP, DAMAGE TO THE GUIDEWIRE, OR VESSEL INJURY."

    Description of Event or Problem · 1

    DURING ROUTINE PCI OF CORONARY ARTERY DR K USED SPECTRE WIRE AS A BUDDY WIRE TO DELIVER STENT. DR. TRAPPED/JAILED SPECTRE WIRE WITH STENT AND SPECTRE WIRE KNUCKLED, AND GOT STUCK ON DISTAL STRUTS OF STENT AND WAS BROKEN WHEN HE ATTEMPTED TO REMOVE SPECTRE GW. TIP OF SPECTRE WAS LEFT BEHIND IN VESSEL, AND A SECOND STENT WAS DEPLOYED TO COVER WIRE. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281971 SPECTRE GUIDEWIRE CATHETER GUIDEWIRE DQX VASCULAR SOLUTIONS, INC. 7386 619194 M20673861

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention