BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2051187 · Received April 6, 2011

    Report

    Report Number
    2182269-2011-00062
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. 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 INSTRUCTIONS FOR USE (IFU) STATE THAT BASED ON CLINICAL EXPERIENCE, THROMBOSIS AT THE PUNCTURE SITE IS A RISK OR SITUATION ASSOCIATED WITH THE USE OF THE ANGIO-SEAL DEVICE OR VASCULAR ACCESS PROCEDURES, IF THROMBUS AT THE PUNCTURE SITE IS SUSPECTED, THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS EVENT MAY INCLUDE THROMBOLYSIS, PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A DIAGNOSTIC HEART CATHETERIZATION PROCEDURE AND AN ANGIO-SEAL WAS SELECTED FOR CLOSURE VIA THE RIGHT FEMORAL ARTERIOTOMY. AT SOME POINT AFTER DEPLOYMENT, THE PATIENT DEVELOPED A COLD LEG. THE PHYSICIAN GAINED ACCESS THROUGH THE LEFT FEMORAL ARTERY AND ADVANCED A SHEATH TO EVALUATED BLOOD FLOW THROUGH THE RIGHT LEG. AN ANGIOGRAM WAS PERFORMED, WHICH REVEALED THROMBUS AT THE SITE WHERE THE ANGIO-SEAL WAS PLACED. A THROMBECTOMY PROCEDURE WAS PERFORMED ON A FOCAL LESION IN THE RIGHT FEMORAL ARTERY. THE PATIENT WAS KEPT TWO NIGHTS IN THE HOSPITAL IN ORDER TO REVASCULARIZE THE RIGHT LEG. THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R VERAPAMIL (DOSAGES UNK)| ASPIRIN PRAVASTATIN| THE PATIENT'S MEDICATIONS INCLUDE:| AROMASIN| LORAZEPAM