BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1891726 · Received November 5, 2010

    Report

    Report Number
    2939204-2010-01044
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K022357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. THE DEVICE IS NOT AVAILABLE; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. INFORMATION AVAILABLE INDICATED THAT SOME RESISTANCE DURING REPOSITIONING OF THE DEVICE WAS ENCOUNTERED, AND THE PATIENT¿S ANATOMY WAS DESCRIBED AS MILD. THE EXACT ROOT CAUSE OF THE RESISTANCE EXPERIENCED DURING REPOSITIONING CANNOT BE DETERMINED. HOWEVER, IT IS PROBABLE THAT RESISTANCE ENCOUNTERED COULD HAVE HINDERED MOVEMENT OF THE GUIDEWIRE. THE RISK OF THE REPORTED EVENT IS NOTED WITHIN THE DIRECTION FOR USE (DFU). THEREFORE, A ROOT CAUSE OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REPOSITIONING OF THE GUIDEWIRE, PAVARIN (DOSE UNKNOWN) WAS ADMINISTERED TO TREAT A VESSEL SPASM. ONE DAY POST THE INDEX PROCEDURE, THE PATIENT EXPERIENCED DIZZINESS AND OCULOMOTOR IMPEDIMENT. THE PHYSICIAN FOUND 'A LITTLE HEMORRHAGE (EXACT LOCATION UNKNOWN)'. NO SPECIAL TREATMENT WAS ADMINISTERED TO THE PATIENT IN RESPONSE TO THE BLEEDING, AND THE PATIENT'S WAS REPORTED TO HAVE A SMALL HEMATOMA ANTERIOR TO THE BRAIN STEM THAT RESULTED IN MILD DYSFUNCTION OF THE LEFT EYE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REPOSITIONING OF THE GUIDEWIRE, PAVARIN (DOSE UNKNOWN) WAS ADMINISTERED TO TREAT A VESSEL SPASM. ONE DAY POST THE INDEX PROCEDURE, THE PATIENT EXPERIENCED DIZZINESS AND OCULOMOTOR IMPEDIMENT. THE PHYSICIAN FOUND "A LITTLE HEMORRHAGE (EXACT LOCATION UNKNOWN)". NO SPECIAL TREATMENT WAS ADMINISTERED TO THE PATIENT IN RESPONSE TO THE BLEEDING, AND THE PATIENT'S WAS REPORTED TO HAVE A SMALL HEMATOMA ANTERIOR TO THE BRAIN STEM THAT RESULTED IN MILD DYSFUNCTION OF THE LEFT EYE.

    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 13239403

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R ENVOY GUIDECATHETER (CORDIS)| PROWLER 14 MICROCATHETER (CODMAN/J&J)