BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE

    MDR report key: 1910506 · Received November 19, 2010

    Report

    Report Number
    2182269-2010-00215
    Event Type
    Injury
    Date Received
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT BLEEDING OR A 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 AND IF NECESSARY, MONITOR PEDAL PULSES. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES IF PTS HAVE CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE, BASED ON PUBLISHED MEDICAL LITERATURE, THE ANGIO-SEAL DEVICE CAN BE DEPLOYED SAFELY IN PT ARTERIES > 5 MM DIAMETER WHEN THERE IS FOUND TO BE NO LUMINAL NARROWING OF 40% OR GREATER WITHIN 5 MM OF THE PUNCTURE SITE. J VASC INTERV RADIOL 2010: 21: 1487 - 1488. DRS D. TESO & R. KARMY-JONES ET AL.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE JOURNAL OF VASCULAR INTERVENTIONAL RADIOLOGY THAT AN ANGIO-SEAL WAS DEPLOYED. MANUAL COMPRESSION HAD TO BE APPLIED TO ACHIEVE HEMOSTASIS. TWO DAYS AFTER DEPLOYMENT A PT PRESENTED WITH SEVERE CLAUDICATION AFTER ANGIOPLASTY, WITH ACUTE SEVERE CLAUDICATION, WHICH REQUIRED AN OPEN EMBOLECTOMY PROCEDURE. SURGICAL FINDINGS REPORTED THAT THE ANGIO-SEAL WAS INTRA-ARTERIAL. ADDITIONAL INFO WAS NOT AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R