BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL EVOLUTION

    MDR report key: 1980345 · Received February 2, 2011

    Report

    Report Number
    2182269-2011-00015
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    December 14, 2010
    Report Date
    February 2, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. IT SHOULD BE NOTED THAT THE REPORTED INCIDENT DATE WAS AFTER THE PRODUCT USE BEFORE DATE. BASED ON THE INFO PROVIDED TO ST. JUDE MEDICAL, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTION THAT A PSEUDOANEURYSM IS A POSSIBLE RISK ASSOCIATED WITH THE USE OF THE ANGIO-SEAL DEVICE OR VASCULAR ACCESS PROCEDURES. IF SUSPECTED, THESE CONDITIONS MAY BE EVALUATED WITH DUPLEX ULTRASOUND. WHEN INDICATED, ULTRASOUND-GUIDED COMPRESSION OF A PSEUDOANEURYSM MAY BE USED AFTER THE ANGIO-SEAL DEVICE HAS BEEN PLACED. THE ANGIO-SEAL DEVICE PT'S INFO GUIDE, WHICH THE PT IS INSTRUCTED TO CARRY WITH THEM FOR 90 DAYS STATES SOME BRUISING OR DISCOMFORT IS COMMON DURING THE HEALING PROCESS AFTER INTRAVASCULAR PROCEDURES; HOWEVER, IF ANY OF THE FOLLOWING SYMPTOMS ARE EXPERIENCED THE PT IS TO CONTACT THEIR PHYSICIAN IMMEDIATELY AT THE NUMBER LISTED ON THEIR PT INFO CARD: FEVER, BLEEDING, PERSISTENT TENDERNESS IN THE GROIN OR SWELLING, REDNESS AND/OR WARM TO TOUCH, NUMBNESS, TINGLING OR PAIN IN THE EXTREMITY WHEN AMBULATING, RASH, WOUND DRAINAGE, OR ANY OTHER UNUSUAL SYMPTOMS. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE DISPLAYS A SYMBOL TO ILLUSTRATE A USE BEFORE DATE. THE ANGIO-SEAL PACKAGING LABEL IS PRINTED WITH THIS SYMBOL AND THE DATE DESIGNED AS THE USE BEFORE DATE. THE DEVICE USED IN THIS EVENT EXCEEDED THE USE BEFORE DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED A PT HAD AN INTERVENTIONAL PROCEDURE AND AN ANGIO-SEAL WAS DEPLOYED VIA THE RIGHT FEMORAL ARTERY. ON (B)(6) 2010, AN ULTRASOUND WAS PERFORMED AND A PSEUDOANEURYSM WAS DETECTED IN THE RIGHT FEMORAL ARTERY, WHICH REQUIRED AN INTERVENTIONAL PROCEDURE AND A STENT WAS DECIDED TO BE PLACED TO REPAIR THE ARTERY WALL. THE PT WAS TAKING PRESCRIBED MEDICATIONS PLAVIX AND ASPIRIN (DOSAGE UNK). THE PT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL EVOLUTION ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL NA 2765104

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R