BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 4

    MDR report key: 1923419 · Received December 13, 2010

    Report

    Report Number
    2939204-2010-01124
    Event Type
    Death
    Date Received
    December 13, 2010
    Date of Event
    July 9, 2010
    Report Date
    November 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K022357
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE RETURNED DEVICE WAS NOTED TO HAVE FRACTURED 296CM FROM THE PROXIMAL END. THE FRACTURED TIP WAS NOT RETURNED FOR ANALYSIS. A KINK WAS NOTED APPROXIMATELY 2CM FROM THE FRACTURE SITE, BASED ON THE INFORMATION PROVIDED THIS MOST LIKELY OCCURRED WHEN THE DEVICE BECAME STUCK IN THE LESION. SCANNING ELECTRON MICROSCOPY REVEALED THAT THE FRACTURE SITE EXHIBITED FATIGUE STRIATIONS ALONG WITH MICROCRACKS/TEARS THAT ARE INDICATIVE OF BENDING. THE DEVICE FRACTURED DUE TO A CYCLIC BENDING MOTION. NO MATERIAL ANOMALIES WERE NOTED. A REVIEW OF LABELING FOUND THAT STROKE AND THE PATIENT OUTCOME OF DEATH ARE NOTED WITHIN THE DIRECTIONS FOR USE (DFU) AS POTENTIAL COMPLICATIONS ASSOCIATED WITH SUCH PROCEDURES. THEREFORE THESE EVENTS ARE CONSIDERED TO BE ANTICIPATED PROCEDURAL COMPLICATIONS. BASED ON THE INVESTIGATION AND INFORMATION PROVIDED, IT IS MOST LIKELY THAT A SUFFICIENT BENDING FORCE WAS APPLIED AFTER IT BECAME STUCK IN THE LESION RESULTING THE DEVICE BREAKING. THEREFORE, THE MOST PROBABLE CAUSE OF THE REPORTED DEVICE TIP BREAK IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    (B)(4): THE REPORTED TIP BREAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE DEVICE BROKE OFF AFTER BECOMING STUCK IN THE STENOSIS IN THE RIGHT INTERNAL CAROTID ARTERY. THE TIP MIGRATED, RESULTING IN "OCCLUSION OF PROXIMAL ORIFICE OF THE STENOSIS DURING 30 MN". THE PIECE WAS RETRIEVED USING THE MICROCATHETER. THE PATIENT WAS REPORTED TO HAVE SUFFERED A DEFICIT OF THE LEFT UPPER EXTREMITY AS A RESULT OF THIS ISSUE. THE PATIENT DIED THIRTEEN DAYS POST PROCEDURE DUE TO A "RIGHT TOTAL ISCHEMIC CEREBROVASCULAR ACCIDENT ON STENT (NON-BOSTON SCIENTIFIC) OCCLUSION".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE DEVICE BROKE OFF AFTER BECOMING STUCK IN THE STENOSIS IN THE RIGHT INTERNAL CAROTID ARTERY. THE TIP MIGRATED, RESULTING IN "OCCLUSION OF PROXIMAL ORIFICE OF THE STENOSIS DURING 30 MN". THE PIECE WAS RETRIEVED USING THE MICROCATHETER. THE PATIENT WAS REPORTED TO HAVE SUFFERED A DEFICIT OF THE LEFT UPPER EXTREMITY AS A RESULT OF THIS ISSUE. THE PATIENT DIED THIRTEEN DAYS POST PROCEDURE DUE TO A "RIGHT TOTAL ISCHEMIC CEREBROVASCULAR ACCIDENT ON STENT (NON-BOSTON SCIENTIFIC) OCCLUSION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 4 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M003468150 0013324428

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death| O