BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC-10 360 10MM X 30CM SR

    MDR report key: 3112319 · Received May 14, 2013

    Report

    Report Number
    3008853977-2013-00150
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 25, 2013
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K042539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE MAIN COIL WAS DETACHED BEYOND THE MAIN JUNCTION. THE MAIN COIL WAS NOTED TO BE STRETCHED. BASED ON THE INFORMATION AVAILABLE, IT IS PROBABLE THAT PROCEDURAL FACTORS LIMITED THE DEVICE PERFORMANCE DURING PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT COIL EMBOLIZATION OF AN ANEURYSM LOCATED IN THE RIGHT POSTERIOR COMMUNICATING ARTERY. PRIOR TO DEPLOYING THE COIL, THE PHYSICIAN NOTED THAT THE COIL WAS TOO BIG FOR THE ANEURYSM. WHILE RETRACTING THE COIL BACK INTO THE MICROCATHETER, WHEN APPROXIMATELY 50% OF THE COIL WAS IN THE MICROCATHETER, THE COIL DETACHED FROM THE DELIVERY WIRE. THE PHYSICIAN CAREFULLY PULLED BACK ON THE MICROCATHETER UNTIL THE COIL ADHERED TO THE TIP OF THE GUIDE CATHETER AT WHICH POINT HE REMOVED THE ENTIRE SYSTEM FROM THE PATIENT. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT COIL EMBOLIZATION OF AN ANEURYSM LOCATED IN THE RIGHT POSTERIOR COMMUNICATING ARTERY. PRIOR TO DEPLOYING THE COIL, THE PHYSICIAN NOTED THAT THE COIL WAS TOO BIG FOR THE ANEURYSM. WHILE RETRACTING THE COIL BACK INTO THE MICROCATHETER, WHEN APPROXIMATELY 50% OF THE COIL WAS IN THE MICROCATHETER, THE COIL DETACHED FROM THE DELIVERY WIRE. THE PHYSICIAN CAREFULLY PULLED BACK ON THE MICROCATHETER UNTIL THE COIL ADHERED TO THE TIP OF THE GUIDE CATHETER AT WHICH POINT HE REMOVED THE ENTIRE SYSTEM FROM THE PATIENT. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212243 GDC-10 360 10MM X 30CM SR DEVICE NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 14716492

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR GUIDER (BOSTON SCIENTIFIC)| TRANSEND (BOSTON SCIENTIFIC)| EXCELSIOR SL-10 (STRYKER)