BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND GUIDEWIRE

    MDR report key: 1757189 · Received July 14, 2010

    Report

    Report Number
    2939204-2010-00794
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    DQX
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: K934122; K931584; K944677; K971254; K022357 AND K931584.

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: K934122; K931584; K944677; K971254; K022357 AND K931584. VISUAL INSPECTION OF THE RETURNED GUIDEWIRE FOUND THE SPRING TIP WAS KINKED AT APPROXIMATELY 0.5CM FROM THE DISTAL TIP AND THE ENTIRE SPRING TIP WAS COILED WITH ONLY APPROXIMATELY 17CM OF ITS REMAINING STRAIGHT PRIOR TO WHERE THE COREWIRE BEGINS. THE SPRING TIP WAS ALSO ELONGATED 3MM IN LENGTH FROM THE SOLDER JOINT. THE GUIDEWIRE SHAFT WAS KINKED AT APPROXIMATELY 142.5CM AND 149.2CM FROM ITS PROXIMAL END. BASED ON THE INVESTIGATION RESULTS AND THE INFORMATION PROVIDED, THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING. THE DAMAGES NOTED ON THE RETURNED DEVICE WERE MOST LIKELY CAUSED BY EXCESSIVE FORCE APPLIED TO THE DEVICE IN ATTEMPTS TO ADVANCE OR RETRACT THE SYSTEM, WHICH MAY HAVE CONTRIBUTED TO THE VESSEL DISSECTION. THEREFORE; A ROOT CAUSE OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED TO THE EVENT.

    Description of Event or Problem · 1

    SEVERE RESISTANCE WAS ENCOUNTERED AT THE INTERNAL CAROTID ARTERY (ICA) CARVERNOUS SEGMENT WHILE THE STENT DELIVERY SYSTEM WAS ADVANCED TO THE MIDDLE CEREBRAL ARTERY (MCA) STENOTIC LESION. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE WHOLE SYSTEM FROM THE PATIENT. ANGIOGRAPHY TAKEN POST THE DELIVERY SYSTEM REMOVAL REVEALED A VESSEL INTIMAL DISSECTION. HOWEVER, BLOOD FLOW WAS NOT LIMITED BY THE EVENT. THE PROCEDURE WAS ABORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SEVERE RESISTANCE WAS ENCOUNTERED AT THE INTERNAL CAROTID ARTERY (ICA) CARVERNOUS SEGMENT WHILE THE STENT DELIVERY SYSTEM WAS ADVANCED TO THE MIDDLE CEREBRAL ARTERY (MCA) STENOTIC LESION. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE WHOLE SYSTEM FROM THE PATIENT. ANGIOGRAPHY TAKEN POST THE DELIVERY SYSTEM REMOVAL REVEALED A VESSEL INTIMAL DISSECTION. HOWEVER, BLOOD FLOW WAS NOT LIMITED BY THE EVENT. THE PROCEDURE WAS ABORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MIAMI UNK532

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other WINGSPAN STENT SYSTEM (BOSTON SCIENTIFIC)