BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRANSEND EX 014/205 PLATINUM

    MDR report key: 5331029 · Received December 28, 2015

    Report

    Report Number
    3008853977-2015-00543
    Event Type
    Death
    Date Received
    December 28, 2015
    Date of Event
    November 12, 2011
    Report Date
    December 7, 2015
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K971254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISPOSED IN THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER OF THE DEVICE IS NOT KNOWN. THE DEVICE WAS NOT RETURNED FOR ANALYSIS THEREFORE VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATIONS NONCONFORMANCE OR MISUSE. THERE IS ALSO NO INDICATION THAT THE SUBJECT DEVICE MALFUNCTIONED. PATIENT VESSEL PERFORATION, HEMORRHAGE, STROKE, INFECTION, DEATH AND COMPLICATIONS ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DELIVERY TO THE TARGET POSTERIOR CEREBRAL ARTERY (PCA) LESION, THE TIP OF THE SUBJECT GUIDEWIRE WAS ACCIDENTALLY INSERTED INTO A PERFORATOR BRANCH SEVERAL TIMES. POST PROCEDURE, ASYMPTOMATIC INTRACRANIAL HEMORRHAGE (ICH) WAS NOTICED IN THE RIGHT THALAMUS AREA. THE NEXT DAY, A LEFT CEREBELLAR HEMISPHERE INFARCTION WAS OBSERVED WITH AN OBSTRUCTIVE HYDROCEPHALUS. THE PATIENT UNDERWENT AN EXTERNAL DECOMPRESSION, AND AN EXTERNAL VENTRICULAR DRAINAGE WAS PLACED. EIGHT DAYS POST PROCEDURE, THE PATIENT DIED. THE CAUSE OF DEATH WAS SEPSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DELIVERY TO THE TARGET POSTERIOR CEREBRAL ARTERY (PCA) LESION, THE TIP OF THE SUBJECT GUIDEWIRE WAS ACCIDENTALLY INSERTED INTO A PERFORATOR BRANCH SEVERAL TIMES. POST PROCEDURE, ASYMPTOMATIC INTRACRANIAL HEMORRHAGE (ICH) WAS NOTICED IN THE RIGHT THALAMUS AREA. THE NEXT DAY, A LEFT CEREBELLAR HEMISPHERE INFARCTION WAS OBSERVED WITH AN OBSTRUCTIVE HYDROCEPHALUS. THE PATIENT UNDERWENT AN EXTERNAL DECOMPRESSION, AND AN EXTERNAL VENTRICULAR DRAINAGE WAS PLACED. EIGHT DAYS POST PROCEDURE, THE PATIENT DIED. THE CAUSE OF DEATH WAS SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853987 TRANSEND EX 014/205 PLATINUM WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| O| R