BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DASHER -14 STEERABLE GUIDEWIRE

    MDR report key: 807860 · Received January 9, 2007

    Report

    Report Number
    6000078-2007-00016
    Event Type
    Injury
    Date Received
    January 9, 2007
    Date of Event
    August 29, 2005
    Report Date
    December 12, 2006
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORP
    Product Code
    DQX
    PMA / PMN Number
    K915115
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT REACHED BOSTON SCIENTIFIC VIA FDA NOTIFICATION OF REPORT FROM THE MAUDE DATABASE. BOSTON SCIENTIFIC WAS ABLE TO LOCATE THE USER FACILITY AND CONTACTED THE FACILITIES RISK MANAGEMENT. UNFORTUNATELY DUE TO CHANGE OF PERSONNEL, RISK MANAGEMENT HAD NO KNOWLEDGE OF THE REPORTED EVENT AND COULD NOT PROVIDE BOSTON SCIENTIFIC WITH ANY FURTHER INFO ON THE DEVICE ITSELF SUCH AS A LOT NUMBER. THEREFORE, BASED SOLELY ON THE INFO PROVIDED IN THE INITIAL REPORT REC'D BY THE FDA, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IF THE USER FACILITY IS EVER ABLE TO PROVIDE ANY ADDITIONAL SIGNIFICANT INFO, BOSTON SCIENTIFIC WILL SUBMIT A SUPPLEMENTAL REPORT. UNTIL SUCH TIME NEW INFO IS REC'D, BOSTON SCIENTIFIC WILL CONSIDER THIS MATTER CLOSED. ADD'L G5. K950069.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A PT WAS UNDERGOING AN EMBOLIZATION PROCEDURE FOR UTERINE FIBROIDS WHEN THE TIP OF GUIDEWIRE REPORTEDLY FRACTURED AND LODGED IN THE PT'S SMALL INTERNAL ILIAC ARTERY BRANCH. CONTINUED BLOOD FLOW WAS REPORTEDLY VISIBLE AROUND AND BEYOND THE LODGED FRAGMENT. THE USER FACILITY REPORTED THE FRAGMENT WAS UNABLE TO RETRIEVED. NO ADDITIONAL INFO WAS DISCLOSED, INCLUDING WHAT SURGICAL OR MEDICAL INTERVENTION WAS NEEDED, AND THE PT'S FINAL OUTCOME AS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DASHER -14 STEERABLE GUIDEWIRE (74DQX) GUIDE WIRE DQX NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORP 234714 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention