BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2051188 · Received April 6, 2011

    Report

    Report Number
    3003681312-2011-00019
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 17, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO
    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. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED TO ST. JUDE MEDICAL, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED A PT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE AND AN ANGIO-SEAL WAS SELECTED FOR CLOSURE IN THE RIGHT FEMORAL ARTERIOTOMY. THE FOLLOWING DAY, THERE WAS A POPPING SENSATION FELT FROM THE GROIN AREA, AS THE PT WAS GETTING READY TO LEAVE THE HOSP. MANUAL COMPRESSION WAS APPLIED AND A PRESSURE BAND WAS PLACED ON THE PT'S GROIN AREA. THE PRESSURE BAND WAS LATER REMOVED, BUT THERE WAS STILL BLEEDING FROM THE PUNCTURE SITE. THE PT WAS TAKEN IN FOR AN ULTRASOUND, WHICH REVEALED THAT A HEMATOMA WAS PRESENT. THE PT WAS KEPT IN THE HOSP FOR FURTHER MONITORING. THE PT WAS REPORTED TO BE STABLE AND WAS LATER DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL PUERTO RICO NA 3226267

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R THE PT WAS TAKING THE FOLLOWING MEDICATIONS:| CLOPIDIGREL 600 MG INITIAL LOADING DOSAGE AND| 75 MG DAILY THEREAFTER.| ASPIRIN 75MG