BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDE WIRES

    MDR report key: 1031789 · Received April 21, 2008

    Report

    Report Number
    2134265-2008-01141
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQO
    PMA / PMN Number
    K923480
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE GUIDE WIRE WILL BE RETAINED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A GUIDE WIRE TIP DETACHMENT OCCURRED. THE LESION WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE PHYSICIAN WAS ABLE TO ADVANCE THE GUIDE WIRE WITH EASE; HOWEVER, 2 CM OF THE GUIDE WIRE TIP "SHEARED OFF" IN A SEPTAL BRANCH OF THE LAD, AND REMAINS IN THE PATIENT. NO ATTEMPT WAS MADE TO RETRIEVE THE SEPARATED PORTION OF THE GUIDE WIRE. NO FURTHER INTERVENTION FOR RETRIEVAL OF THE GUIDE WIRE TIP IS PLANNED. THE PROCEDURE WAS COMPLETED WITH THE PLACEMENT OF A STENT. NO FURTHER PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE WIRES DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC GRAPHIX INT J

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other