BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET 360 ULTRA 5MM X 15CM

    MDR report key: 3802869 · Received May 9, 2014

    Report

    Report Number
    3008853977-2014-00151
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 12, 2014
    Report Date
    April 14, 2014
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS DISPOSED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. BASED ON THE ADDITIONAL INFORMATION RECEIVED THE COIL WAS REPOSITIONED. THEREFORE THE MOST PROBABLE CAUSE FOR THE BROKEN COIL IS OPERATIONAL FACTOR.

    Additional Manufacturer Narrative · 1

    DEVICE DISPOSED OF AT HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE ON A RUPTURED ANEURYSM, THE COIL WAS REPOSITIONED AND THE COIL STRETCHED AND BROKE. THE PHYSICIAN SUCCESSFULLY USED A SNARE TO RETRIEVE THE BROKEN COIL. APPROXIMATELY A WEEK POST ADMISSION THE PATIENT DIED. THE PHYSICIAN DOES NOT RELATE THE DEATH THE SUBJECT DEVICE. THE PATIENT DIED DUE TO A GRADE 5 SUBARACHNOID HEMORRHAGE AND VASOSPASM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE ON A RUPTURED ANEURYSM, THE COIL BROKE INSIDE THE CATHETER. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN COIL SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280679 TARGET 360 ULTRA 5MM X 15CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 15780089

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention