BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE STS PLUS PLATFORM

    MDR report key: 1060374 · Received June 11, 2008

    Report

    Report Number
    2182269-2008-00159
    Event Type
    Injury
    Date Received
    June 11, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 15, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WERE NOT POSSIBLE SINCE THE LOT NUMBER WAS UNK. BASED ON THE INFO REC'D THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT BLEEDING OR HEMATOMA AT THE PUNCTURE SITE IS A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE OR VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE. IF NECESSARY, MONITOR PEDAL PULSES. THE ANGIO-SEAL IFU STATES THAT IF THROMBOSIS AT THE PUNCTURE SITE OR COLLAGEN DEPOSITION INTO THE ARTERY IS SUSPECTED, THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS MAY INCLUDE THROMBOLYSIS, PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION. A SEARCH OF THE ANGIO-SEAL TRAINING DATABASE REVEALED NO TRAINING RECORD FOR THE PHYSICIAN. THE IFU CAUTIONS THAT THE ANGIO-SEAL DEVICE IS TO BE USED ONLY BY A LICENSED PHYSICIAN (OR OTHER HEALTH CARE PROFESSIONAL AUTHORIZED BY OR UNDER THE DIRECTION OF SUCH PHYSICIAN) POSSESSING ADEQUATE INSTRUCTION IN THE USED OF THE DEVICE, E.G. PARTICIPATION IN AN ANGIO-SEAL PHYSICIAN INSTRUCTION PROGRAM OR EQUIVALENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHYSICIAN FOLLOWING A PERCUTANEOUS PROCEDURE AND ANGIO-SEAL STS PLUS DEVICE WAS SELECTED FOR USE. THE PT'S PREVIOUS MULTIPLE PERCUTANEOUS PROCEDURES LEFT SCAR TISSUE IN THE ARTERIOTOMY LOCATION. THE ENCOUNTER INSERTION DIFFICULTIES WERE DUE TO THE SCAR TISSUE. THE ANGIO-SEAL STS PLUS WAS DEPLOYED. BLEEDING CONTINUED REQUIRING MANUAL COMPRESSION TO ACHIEVE HEMOSTASIS. THE PT DEVELOPED DIMINISHED PULSES IN THE EXTREMITY. A DUPLEX ULTRASOUND REVEALED A THROMBUS PLUG AND A "STRING LIKE" APPEARANCE. THE PT UNDERWENT SURGICAL INTERVENTION FOR AN OPEN EMBOLECTOMY. THE PHYSICIAN SUSPECTS AN INTRA-ARTERIAL DEPLOYMENT OF THE ANGIO-SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL DEVICE STS PLUS PLATFORM ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention