BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX STRETCH RESISTANT (SR) COILS

    MDR report key: 2020341 · Received March 16, 2011

    Report

    Report Number
    2939204-2011-00122
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ANTICIPATED PROCEDURAL COMPLICATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. THE SUBJECT DEVICE REMAINED IMPLANTED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE THE DEVICE WAS USED IN ACCORDANCE WITH THE DIRECTION FOR USE (DFU). ANEURYSM RUPTURE IS A KNOWN RISK ASSOCIATED WITH COIL EMBOLIZATION PROCEDURES. THEREFORE, A ROOT CAUSE OF ANTICIPATE PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BALLOON ASSISTED COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM LOCATED IN THE LEFT SUPERIOR CEREBELLAR ARTERY, A COIL LOOP PERFORATED THE ANEURYSM. THE PHYSICIAN DILATED THE BALLOON CATHETER TO PREVENT BLEEDING AND DETACHED THE COIL. TWO ADDITIONAL COILS WERE IMPLANTED INTO THE ANEURYSM TO STOP THE BLEEDING. THE PATIENT REMAINED STABLE AND VITALS DID NOT CHANGE. THE PATIENT WAS REPORTING TO BE DOING WELL NINE DAYS POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX STRETCH RESISTANT (SR) COILS DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M003498408SR0 13928353

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other EXCELSIOR SL-10 MICROCATHETER (BOSTON SCIENTIFIC)