BEUDAMED
    FDA Adverse Event Summary report: N

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

    MDR report key: 1893523 · Received November 8, 2010

    Report

    Report Number
    2939204-2010-01043
    Date Received
    November 8, 2010
    Report Date
    October 22, 2010
    Product Code
    DQX
    PMA / PMN Number
    K022357
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE GUIDEWIRE, THE PATIENT'S ANATOMY WAS MODERATE AND A LITTLE EXCESSIVE FORCE WAS USED DURING REMOVAL OF THE DEVICE FROM THE PATIENT'S BODY. THE RISK OF THE REPORTED EVENT IS NOTED WITHIN THE DIRECTION FOR USE (DFU). IT IS LIKELY THAT ANATOMICAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THEREFORE, A ROOT CAUSE OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VESSEL SPASM OCCURRED AS THE GUIDEWIRE WAS BEING REMOVED. PAVARIN (DOSE UNKNOWN) WAS ADMINISTERED AND POST REMOVAL OF THE GUIDEWIRE, A "VERY LITTLE HEMORRHAGE WAS FOUND" (EXACT LOCATION UNKNOWN). IN RESPONSE TO THE BLEEDING, THE PHYSICIAN NEUTRALIZED THE HEPARIN AND DISCONTINUED ASPIRIN FOR TWO DAYS AND THE CLOPIDOGREL FOR ONE DAY. THE PATIENT WAS REPORTED TO HAVE A LIGHT SUBARACHNOID HEMORRHAGE AND THROMBOSIS OF THE RIGHT MIDDLE CEREBRAL ARTERY THAT RESULTED IN PARTIAL APHASIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VESSEL SPASM OCCURRED AS THE GUIDEWIRE WAS BEING REMOVED. PAVARIN (DOSE UNKNOWN) WAS ADMINISTERED AND POST REMOVAL OF THE GUIDEWIRE, A "VERY LITTLE HEMORRHAGE WAS FOUND" (EXACT LOCATION UNKNOWN). IN RESPONSE TO THE BLEEDING, THE PHYSICIAN NEUTRALIZED THE HEPARIN AND DISCONTINUED ASPIRIN FOR TWO DAYS AND THE CLOPIDOGREL FOR ONE DAY. THE PATIENT WAS REPORTED TO HAVE A LIGHT SUBARACHNOID HEMORRHAGE AND THROMBOSIS OF THE RIGHT MIDDLE CEREBRAL ARTERY THAT RESULTED IN PARTIAL APHASIA.

    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 M003468150

    Patients

    Seq Age Sex Outcome Treatment
    1 ENVOY GUIDE CATHETER (CORDIS)