BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 1871221 · Received October 3, 2010

    Report

    Report Number
    2954740-2010-00019
    Event Type
    Injury
    Date Received
    October 3, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 16, 2010
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    MJN
    PMA / PMN Number
    K091504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LIST OF DEVICES USED INCLUDING EXPIRATION DATES: CATALOG #: CRC140615; MFG DATE: 08/2007; EXPIRATION DATE: 08/31/2010. CATALOG #: CHE100610-30; LOT #: F46582; MFG DATE: 10/2008; EXPIRATION DATE: 10/31/2011. CATALOG #: CHE100510-30; LOT #: F44029; MFG DATE: 06/2008; EXPIRATION DATE: 06/30/2011. CATALOG #: CHE100410-30; LOT #: F61444; MFG DATE: 05/2010; EXPIRATION DATE: 05/31/2015. CATALOG #: CFS100408-30; LOT #: F56304; MFG DATE: 03/2010; EXPIRATION DATE: 03/31/2015. CATALOG #: CFS100204-30; LOT #: F61414; MFG DATE: 05/2010; EXPIRATION DATE: 05/31/2015. CATALOG #: CFS100202-30; LOT #: F60168; MFG DATE: 03/2010; EXPIRATION DATE: 03/31/2015. CATALOG #: CFS100201-30; LOT #: F57767; MFG DATE: 03/2010; EXPIRATION DATE: 03/31/2015. CATALOG #: CFS100202-30; LOT #: F57034; MFG DATE: 02/2010; EXPIRATION DATE: 02/28/2015. CATALOG #: CFS100201-30; LOT #: F240641; MFG DATE: 01/2006; EXPIRATION DATE: 01/31/2008. CATALOG #: CFS100302-30; LOT #: F24061; MFG DATE: 01/2006; EXPIRATION DATE: 01/31/2008. CATALOG #: CFS100203-30; LOT #: F55729; MFG DATE: 09/2009; EXPIRATION DATE: 09/30/2014. THE ABOVE DEVICES HAVE BEEN IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION. THE MANUFACTURING RECORDS FOR THESE LOTS WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS. A SEARCH OF OUR FIELD SURVEILLANCE DATABASE YIELDED NO OTHER COMPLAINTS OF THIS TYPE WITH THESE LOTS.

    Description of Event or Problem · 1

    PHYSICIAN ALLEGED POSSIBLE HYPERSENSITIVITY REACTION TO POLYGLYCOLIC ACID (PGA) SUTURE USED IN THE MICROCOIL. PT FIRST COMPLAINED OF SEVERE IRRITATION AT THE ANGIOSEAL SITE WHERE SIMILAR SUTURE WAS USED. FIVE WEEKS POST PROCEDURE, PT COMPLAINED OF DEFICIT IN LEFT ARM AND RETURNED FOR EVALUATION. MD DISCOVERED EXTENSIVE RIGHT HEMISPHERE EDEMA NEAR THE COILING SITE. TESTS FOR INFECTION WERE NEGATIVE, HOWEVER, PT REQUIRED ADDITIONAL HOSPITAL STAY AND MEDICAL INTERVENTION AS A RESULT OF THE EDEMA. PER REC'D REPORT, PT IS STABLE AND RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL MJN MICRUS ENDOVASCULAR CORPORATION F58632

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R