BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX STRETCH RESISTANT (SR) COILS

    MDR report key: 2103243 · Received May 25, 2011

    Report

    Report Number
    2939204-2011-00320
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FROM THE USER FACILITY STATED THAT THERE WERE NO ISSUES NOTED TO THE COIL OR THE MICROCATHETER. THE PHYSICIAN RELATES THE REPORTED EVENT TO THE NATURE OF THE ANEURYSM.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE WAS NOT RETURNED FOR EVALUATION. FROM THE INFORMATION PROVIDED, THE PHYSICIAN ATTRIBUTED THE DIFFICULTIES ENCOUNTERED ON THE SIZE OF THE ANEURYSM THAT RESULTED IN THE RUPTURE OF THE ANEURYSM. A REVIEW OF THE DEVICE LABELING FOUND THAT REPORTED EVENTS ARE NOTED WITHIN THE DIRECTIONS FOR USE AS POTENTIAL RISKS ASSOCIATED WITH SUCH PROCEDURES. THE MANUFACTURING RECORDS FOR THIS PRODUCT HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. BASED ON ALL THE AVAILABLE INFORMATION IT WAS CONCLUDED THAT OPERATIONAL CONTEXT WAS THE MOST LIKELY CAUSE OF THE REPORTED EVENTS.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO COIL EMBOLIZE A SMALL ANTERIOR COMMUNICATING ARTERY ANEURYSM THAT THE PHYSICIAN DESCRIBED AS "TOO NARROW AND TIGHT". AS THE DEVICE, FIRST COIL, WAS BEING DEPLOYED INTO THE ANEURYSM THE MICROCATHETER UNEXPECTEDLY MOVED BACK. THE PHYSICIAN ATTEMPTED TO DEPLOY THE COIL AGAIN BUT THE MICROCATHETER MOVED UNEXPECTEDLY AGAIN AND THE ANEURYSM RUPTURED. THE PATIENT WAS SENT TO SURGERY TO TREAT THE RUPTURED ANEURYSM AND IS REPORTED TO BE IN A STABLE CONDITION.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO COIL EMBOLIZE A SMALL ANTERIOR COMMUNICATING ARTERY ANEURYSM THAT THE PHYSICIAN DESCRIBED AS "TOO NARROW AND TIGHT". AS THE DEVICE, FIRST COIL, WAS BEING DEPLOYED INTO THE ANEURYSM THE MICROCATHETER UNEXPECTEDLY MOVED BACK. THE PHYSICIAN ATTEMPTED TO DEPLOY THE COIL AGAIN BUT THE MICROCATHETER MOVED UNEXPECTEDLY AGAIN AND THE ANEURYSM RUPTURED. THE PATIENT WAS SENT TO SURGERY TO TREAT THE RUPTURED ANEURYSM AND IS REPORTED TO BE IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX STRETCH RESISTANT (SR) COILS DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M003498304SR0 13793884

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXCELSIOR MICROCATHETER (BOSTON SCIENTIFIC)