BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL STS PLUS DEVICE

    MDR report key: 1241300 · Received November 20, 2008

    Report

    Report Number
    2182269-2008-00317
    Event Type
    Injury
    Date Received
    November 20, 2008
    Report Date
    November 20, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION 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 OPTION INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL PATIENT INFORMATION GUIDE STATES SOME BRUISING OR DISCOMFORT IS COMMON DURING THE HEALING PROCESS AFTER INTRAVASCULAR PROCEDURES; HOWEVER, THE PATIENT SHOULD CONTACT THEIR PHYSICIAN IMMEDIATELY AT THE NUMBER LISTED ON THE PATIENT INFORMATION CARD IF THEY EXPERIENCE FEVER, BLEEDING, PERSISTENT SWELLING IN THE GROIN OR SWELLING, REDNESS AND/OR WARM TO TOUCH, NUMBNESS, TINGLING OR PAIN IN THE EXTREMITY WHEN AMBULATING, RASH, WOULD DRAINAGE OR ANY OTHER UNUSUAL SYMPTOMS.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PRINTED LITERATURE ARTICLE THAT THE PATIENT EXPERIENCED A COMMON FEMORAL VEIN THROMBOSIS ON THE SIDE OF THE ANGIO-SEAL DEPLOYMENT. THE PATIENT PRESENTED ONE WEEK LATER WITH AN EDEMATOUS LEG. THE DIAGNOSIS WAS CONFIRMED ON ULTRASOUND AND ANTICOAGULANT WAS REQUIRED. THE IMPLANT AND INCIDENT DATES ARE BETWEEN 2005-2006. CARDIOVASC. INTERVENT RADIOL. (2007) 30, 182-187).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention