BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2231204 · Received August 25, 2011

    Report

    Report Number
    3003681312-2011-00063
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 25, 2011
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 INFORMATION PROVIDED TO ST. JUDE MEDICAL, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATE THAT THE DEVICE IS INDICATED FOR USE IN CLOSING AND REDUCING TIME TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE IN PTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY PROCEDURES OR INTERVENTIONAL PROCEDURES USING A 8 FRENCH OR SMALLER PROCEDURAL SHEATH FOR THE 8F ANGIO-SEAL DEVICE AND A 6 FRENCH OR SMALLER PROCEDURAL SHEATH FOR THE 6F ANGIO-SEAL DEVICE. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTIONS 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 INSTRUCTIONS FOR USE (IFU) STATES IF PT'S HAVE CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE, BASED ON PUBLISHED MEDICAL LITERATURE, THE ANGIO-SEAL DEVICE CAN BE DEPLOYED SAFELY IN PT ARTERIES > 5 MM DIAMETER WHEN THERE IS FOUND TO BE NO LUMINAL NARROWING OF 40% OR GREATER WITHIN 5 MM OF THE PUNCTURE SITE.

    Description of Event or Problem · 1

    A 6F ANGIO-SEAL VIP WAS DEPLOYED SMOOTHLY AND WITHOUT INCIDENT FOLLOWING A BILATERAL PERCUTANEOUS PROCEDURE. THE ANGIO-SEAL WAS DEPLOYED IN THE RIGHT GROIN AND LEFT GROIN WAS SUCCESSFULLY CLOSED WITH MANUAL COMPRESSION. A PRE-DEPLOYMENT ANGIOGRAM HAD BEEN PERFORMED PRIOR TO DEPLOYMENT. A 7F INTRODUCER SHEATH HAD BEEN USED FOR THE PERCUTANEOUS PROCEDURE. TWELVE HRS FOLLOWING THE PROCEDURE, THE PT EXPERIENCED SEVERE EPIGASTRIC PAIN, BILIARY COLIC, AND REPORTEDLY MOVED AROUND VIOLENTLY AND WITHOUT CARE OR RESTRAINT IN BED FOR A NUMBER OF MINUTES UNTIL THE EPIGASTRIC PAIN EASED. SUBSEQUENTLY, THE PT WAS NOTED TO HAVE PAIN AND SWELLING IN THE RIGHT GROIN. THE PAIN EASED THROUGHOUT DAY AND SWELLING DECREASED. AN ULTRASOUND WAS PERFORMED APPROXIMATELY 24 HRS POST-PROCEDURE AND 11 HRS POST EVENT. AN 8MM PSEUDOANEURYSM WAS IDENTIFIED IN THE RIGHT COMMON FEMORAL ARTERY. A REPEAT ULTRASOUND IS SCHEDULED TO CHECK ON THE STATUS OF THE PSEUDOANEURYSM. THE PT IS REPORTEDLY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 3346548

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R PLAVIX (75 MG)| AND ANTI-COAGULANTS AS PRESCRIBED.| THE PT TAKES ASPIRIN (100MG) DAILY,