BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC 10-ULTRASOFT STRETCH RESISTANT COIL

    MDR report key: 665522 · Received January 16, 2006

    Report

    Report Number
    6000078-2005-00269
    Event Type
    Injury
    Date Received
    January 16, 2006
    Date of Event
    December 13, 2005
    Report Date
    January 13, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT AVAILABLE FOR A TECHNICAL ANALYSIS BECAUSE IT WAS DISPOSED OF AT THE USER FACILITY. A REVIEW OF THE DEVICE HISTORY RECORD ACCOMPANIES THIS REPORT. ANALYSIS OF THE SUBJECT DEVICE WAS NOT POSSIBLE BECAUSE IT WAS DISPOSED OF AT THE USER FACILITY. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO ISSUES OR DISCREPANCIES WERE FOUND, WHICH COULD POTENTIALLY RELATE TO THE REPORTED EVENT. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ANOTHER EVENT WAS REPORTED ON THIS BATCH OF FINISHED GOODS; THE REPORTED ISSUE IS UNRELATED TO THE REPORTED EVENT UNDER THIS COMPLAINT. ADDITIONAL INFORMATION RECEIVED THROUGH A CORONARY REPRESENTATIVE STATED THAT THERE NO ISSUES WITH THE SUBJECT DEVICE DURING INSPECTION, PREPARATION, AND NO FRICTION WAS EXPERIENCED WHILE ADVANCING THE MAIN COIL FROM INTRODUCER SHEATH. THE SUBJECT DEVICE WAS ADVANCED SMOOTHLY INTO THE MICROCATHETER. THE SUBJECT DEVICE DID NOT MALFUNCTION IN ANY WAY. NO DAMAGE WAS NOTICED WHEN THE SUBJECT DEVICE WAS REMOVED FROM THE PATIENT. BOSTON SCIENTIFIC MANUFACTURING PROCESS INCLUDE EXTENSIVE TESTING AND INSPECTIONS TO ENSURE EACH PRODUCT MEETS OR EXCEEDS ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE EVENT TOOK PLACE DURING A RE-EMBOLIZATION PROCEDURE PERFORMED AT THE ANTERIOR COMMUNICATING ARTERY FOR COIL COMPACTION, WHICH WAS PREVIOUSLY EMBOLIZED WITH TRUFILL DCS COILS ON A 10 MM ANEURYSM ON 03/2005. AN ENVOY 6FR. MPD GUIDING CATHETER WAS APPROACHED AND THE STATUS OF THE ANEURYSM WAS CONFIRMED UNDER THE ANGIOGRAPHY. IT WAS DIFFICULT TO APPROACH THE ANTERIOR COMMUNICATING ARTERY WITH THE EXCELSIOR 1018 MICROCATHETER AND A TRANSEND EX .014" GUIDEWIRE, AS THE VESSEL WAS VERY TORTUOUS BETWEEN THE RIGHT INTERNAL CAROTID ARTERY AND THE ANTERIOR CEREBRAL ARTERY. THE GUIDEWIRE WAS CHANGED TO A GT 0.16" DOUBLE ANGLE AND 4 TRUFILL DCS COILS WERE DEPLOYED; COMPLEX 5-5, HELICAL 5-8, HELICAL 4-8, AND HELICAL 3-8. THE PHYSICIAN ATTEMPTED TO DEPLOY A HELICAL 3-6, BUT IT WAS REMOVED. THE MICROCATHETER WAS THEN CHANGED TO AN ECHELON 10 (EV3) MICROCATHETER AND THE GUIDEWIRE WAS CHANGED TO A TRANSEND EX .014" GUIDEWIRE. TWO GDC COILS WERE DEPLOYED INTO THE LESION; GDC 10-2D SR 4 MMX8 CM AND GDC 10-ULTRASOFT STRETCH RESISTANT COIL 2MMX6CM. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY A 2MMX3CM GDC 10-ULTRASOFT STRETCH RESISTANT COIL BUT IT WAS REMOVED. WHEN THE GDC 10-ULTRASOFT STRETCH RESISTANT COIL WAS ADVANCED TO THE LSION, THE BLOOD FLOW DISAPPEARED AT THE LEFT A2 AREA UNDER ANGIOGRAPHY BEFORE DETACHMENT. UROKINASE WAS ADMINISTERED, AS THE PHYSICIAN THOUGHT THAT THE OCCLUSION WAS CAUSED BY THROMBUS. THE PHYSICIAN HAD DIFFICULTIES APPROACHING THE LEFT A2 AREA FROM THE ANTERIOR COMMUNICATING ARTERY WITH THE TRANSEND EX .014" GUIDEWIRE FOR INFUSION OF THE UROKINASE. THE GUIDEWIRE WAS ADVANCED WITH TORQUE; NO FLOW WAS NOTICED AFTER UROKINASE WAS ADMINISTERED; THE PHYSICIAN THOUGHT THAT THE ABSENCE OF THE FLOW WAS CAUSED BY THE THROMBUS, AS THE GDC 10-ULTRASOFT STRETCH RESISTANT COIL WAS MOVED TO THE VESSEL. PTA WAS THEN PERFORMED WITH A GATEWAY 1.5-9 MM AT THE NECK; HOWEVER, NO FLOW WAS OBSERVED. AFTER THIS INCIDENT, EMBOLIZATION WAS ATTEMPTED WITH THE ECHELON 10 MICROCATHETER AND THE TRANSEND EX .014" GUIDEWIRE. WHEN THE TRANSEND EX .014" GUIDEWIRE WAS ADVANCED TO THE TOP OF THE INTERNAL CAROTID ARTERY WITH TORQUE, IT DID NOT MOVE. THE GUIDEWIRE HAD FRACTURED AT 3-CM FROM THE DISTAL TIP. THE FRAGMENT REMAINED NEAR THE M3 AREA (MFR REPORT# 2000078-2005-00266). THE FRAGMENT WAS SUCCESSFULLY REMOVED FROM THE BODY WITH THE AID OF A GOOSE NECK. THE PROCEDURE WAS REPORTED TO HAVE BEEN SUCCESSFULLY COMPLETED AND THE PT WAS REPORTED TO BE IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC 10-ULTRASOFT STRETCH RESISTANT COIL DETACHABLE COIL HCG BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION * 7806803

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening