BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO 14 NEURO GUIDEWIRE

    MDR report key: 886116 · Received September 14, 2006

    Report

    Report Number
    6000078-2005-00277
    Event Type
    Malfunction
    Date Received
    September 14, 2006
    Date of Event
    June 20, 2005
    Report Date
    June 24, 2005
    Manufacturer
    NEUROVASCULAR, A DIV. OF BOSTON SCIENTIFIC CORP
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IN QUESTION WAS RETURNED TO THE MFR. THE PRODUCTS CONTENTS WERE FOUND INSIDE THE POUCH; HOWEVER, THE BOTTOM OF THE POUCH IS NOT SEALED. A VISUAL EXAMINATION OF THE RETURNED POUCH INDICATED THAT THE POUCH WAS NEVER SEALED IN THE PACKAGING PROCESS OF MFG. THE SPEC FOR THE TYVEK POUCH WAS PULLED SO THAT A MEASUREMENT VERIFICATION OF THE RETURNED POUCH COULD BE DETERMINED, OR AN INDICATION TO WHETHER THE SEAL AT THE BOTTOM OF THE POUCH HAD BEEN CUT OFF OR NEVER SEALED. THE MEASUREMENT OF POUCH IS 10 7/8" X 10 1/4" WHICH MEETS THE SPEC, ALSO NOTED ON THE RETURNED POUCH WERE THE 1/8" TABS FOUND AT THE BOTTOM WHICH ALSO INDICATES THE BOTTOM OF THE POUCH HAD NOT BEEN CUT OFF. SPECS INDICATE THE POUCH SHOULD BE SEALED AT NO MORE THAN 3/4" FROM THE BOTTOMS EDGE; A VISUAL EXAMINATION REVEALS NO EVIDENCE (I.E., IMPRESSIONS, MARKINGS) THAT AN ATTEMPT TO A SEAL POUCH HAD BEEN MADE. THIS INCIDENT HAS BEEN DETERMINED TO BE A MFG PACKAGING RELATED ISSUE. A CORRECTIVE ACTION RESPONSE WAS ISSUED TO ENSURE ALL PACKAGING IS PROPERLY SEALED BEFORE LEAVING THE MFG FACILITY. A DHR REVIEW WAS PERFORMED AND NO ISSUES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. ADD'L: PMA/510(K) # K023700, K002907.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC HAS BECOME AWARE OF THE FOLLOWING EVENT AFTER CONDUCTING A RETROSPECTIVE REVIEW OF COMPLAINT RECORDS: THE PHYSICIAN REPORTED THAT WHEN THE POUCH CONTAINING THE GUIDEWIRE WAS REMOVED FROM THE OUTER BOX, IT WAS DISCOVERED THAT THE BOTTOM OF THE POUCH WAS NOT SEALED.

    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 1301 B04939

    Patients

    Seq Age Sex Outcome Treatment
    1 *