BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1940508 · Received December 21, 2010

    Report

    Report Number
    2182269-2010-00246
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVAL AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO PROVIDED TO ST. JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTION FOR USE (IFU) STATES SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI), AN ANGIO-SEAL STS WAS SELECTED FOR USE. MORE THAN THREE MONTHS LATER, ON (B)(6) 2010, FOLLOWING A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) VIA THE IPSILATERAL FEMORAL ARTERY, ANOTHER ANGIO-SEAL WAS USED. A 6F TERUMO SHEATH WAS ALSO USED DURING A PPI PROCEDURE. A PRE-DEPLOYMENT ANGIOGRAM REVEALED A COMMON FEMORAL ARTERY (CFA). HEMOSTASIS WAS ACHIEVED. THREE HOURS LATER, THE PT EXPERIENCED SUBCUTANEOUS BLEEDING AROUND THE PUNCTURE SITE AND MANUAL COMPRESSION WAS APPLIED FOR ONE HOUR BUT HEMOSTASIS WAS NOT ACHIEVED. THE PT UNDERWENT AN EMERGENCY SURGERY AND THE ENTIRE ANGIO-SEAL COMPONENTS WERE REMOVED IN PERFORMING AN ANASTOMOSIS. DURING THAT, THE SURGEON FOUND A COLLAGEN LIKE SUBSTANCE DEPLOYED OUTSIDE THE ARTERY AND IT WAS REMOVED. THERE WERE NO REPORTED CONSEQUENCES TO THE PT. NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS ANGIO-SEAL VASCULAR CLOSURE DEVICE MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R