BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO-14 NEURO GUIDEWIRE

    MDR report key: 884988 · Received September 14, 2006

    Report

    Report Number
    6000078-2004-00257
    Event Type
    Malfunction
    Date Received
    September 14, 2006
    Date of Event
    January 1, 2004
    Report Date
    June 11, 2006
    Manufacturer
    NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K) NUMBERS: K023700, K002907. THE DEVICE IN QUESTION WAS RETURNED TO BOSTON SCIENTIFIC FOR EVAL. A DEVICE HISTORY RECORD (DHR) REVIEW, AN INITIAL CONDITION EXAM AND A VISUAL/MICROSCOPIC EXAM WERE PERFORMED AS PART OF THE DEVICE EVAL. ALSO, PRIOR EXPERIMENTAL DATA ATTEMPTING TO REPRODUCE THE FAILURE WAS INCLUDED AS PART OF THE DEVICE EVAL. THE DHR REVIEW CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE IN QUESTION WAS RETURNED PARTIALLY WITHDRAWN FROM THE HOOP USED IN PACKAGING IN A CLEAR PLASTIC BAG. THE DISTAL TIP HAD A KINK AND VISIBLE DAMAGE. RESULTS FROM THE VISUAL/MICROSCOPIC EXAM SHOWED A SEPARATION AT THE DISTAL TIP; HOWEVER, THE BREAK DISPLAYED CHARACTERISTICS WHICH WERE NOT INDICATIVE OF A TENSILE OR TORSIONAL TYPE BREAK. IT WAS POSTULATED THAT THE BREAK IN THE DEVICE OCCURRED UPON REMOVAL FROM PACKAGING, HOWEVER, EFFORTS TO REPRODUCE THIS BREAK IN THE LAB WERE UNSUCCESSFUL. BASED ON THE ABOVE FACTS AND FINDINGS. THE USER'S COMPLAINT WAS CONFIRMED; HOWEVER, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IF FURTHER SIGNIFICANT INFO IS FOUND, A SUPPLEMENTAL REPORT WILL FOLLOW.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC HAS BECOME AWARE OF THE FOLLOWING EVENT AFTER CONDUCTING A RETROSPECTIVE REVIEW OF COMPLAINT RECORDS: THE HOSP REPORTED THAT THE DEVICE IN QUESTION WAS BENT WHEN THEY REMOVED IT FROM PACKAGING. THE HOSP REPORTED THAT THEY USED ANOTHER DEVICE FOR THIS ANEURYSM EMBOLIZATION PROCEDURE AND THAT THE PT STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO-14 NEURO GUIDEWIRE GUIDEWIRE DQX NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP 13010 B03511

    Patients

    Seq Age Sex Outcome Treatment
    1 *