BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX STRETCH RESISTANT (SR) COILS

    MDR report key: 1902682 · Received November 18, 2010

    Report

    Report Number
    2939204-2010-01094
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE ISSUES. THE DEVICE REMAINS IMPLANTED SO IS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED IT WAS REPORTED THAT THE DELIVERY WIRE WAS ROTATED AS THE DEVICE WAS BEING REPOSITIONED. THE DIRECTIONS FOR USE STATE: "WARNING: DO NOT ROTATE THE DELIVERY WIRE DURING OR AFTER DELIVERY OF THE COIL INTO THE ANEURYSM. ROTATING THE MATRIX 2 DETACHABLE COIL DELIVERY WIRE MAY RESULT IN A STRETCHED COIL OR PREMATURE DETACHMENT OF THE COIL FROM THE DELIVERY WIRE, WHICH COULD RESULT IN COIL MIGRATION.: IT IS MOST LIKELY THAT THE ROTATION OF THE DELIVERY WIRE DURING THE REPOSITIONING OF THE DEVICE RESULTED IN THE COIL DETACHING AND LEAD TO THE COIL PROTRUSION. THEREFORE, IT WAS DETERMINED THAT USER/USE ERROR WAS THE MOST PROBABLE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FROM THE USER FACILITY STATED THAT THE PHYSICIAN ROTATED THE PUSHER WIRE DURING REPOSITIONING OF THE COIL INTO THE ANEURYSM IN AN ATTEMPT TO MOVE THE MICROCATHETER OVER THE COIL AND INTO THE ANEURYSM. THE PHYSICIAN MADE AN UNSUCCESSFUL ATTEMPT TO DETACH THE COIL AND AS HE WAS ATTEMPTING TO REMOVE THE DEVICE, HE NOTED THAT THE COIL WAS STRETCHED AND DETACHED FROM THE PUSHER WIRE.

    Description of Event or Problem · 1

    DURING A STENT ASSISTED COIL EMBOLIZATION, AS AN ATTEMPT WAS MADE TO DEPLOY THE DEVICE, FOURTH COIL TO BE USED, DIFFICULTIES WERE ENCOUNTERED AND THE COIL DETACHED FROM THE PUSHER WIRE AND BECAME STRETCHED. APPROXIMATELY 2CM OF THE COIL PROTRUDED FROM THE ANEURYSM SO THE PHYSICIAN USED A STENT TO SECURE THIS TO THE VESSEL WALL. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    DURING A STENT ASSISTED COIL EMBOLIZATION, AS AN ATTEMPT WAS MADE TO DEPLOY THE DEVICE, FOURTH COIL TO BE USED, DIFFICULTIES WERE ENCOUNTERED AND THE COIL DETACHED FROM THE PUSHER WIRE AND BECAME STRETCHED. APPROXIMATELY 2CM OF THE COIL PROTRUDED FROM THE ANEURYSM SO THE PHYSICIAN USED A STENT TO SECURE THIS TO THE VESSEL WALL. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX STRETCH RESISTANT (SR) COILS DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M003498308SR0 0013328939

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention EXCELSIOR SL10 MICROCATHETER (BOSTON SCIENTIFIC)| THREE COILS (MODEL UNKNOWN, BOSTON SCIENTIFIC)| NEUROFORM STENT (BOSTON SCIENTIFIC)