BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE

    MDR report key: 2051193 · Received April 6, 2011

    Report

    Report Number
    2182269-2011-00063
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 15, 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
    ND, 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 INSTRUCTIONS FOR USE (IFU) STATES SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE IFU STATES IF PATIENT'S HAVE CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE, BASED ON PUBLISHED MEDICAL LITERATURE, THE ANGIO-SEAL DEVICE CAN BE DEPLOYED SAFELY IN PATIENT 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

    THE (B)(6) PATIENT REPORTED THAT FOLLOWING A HEART CATHETERIZATION ON (B)(6) 2011, AN ANGIO-SEAL WAS PLACED IN HER RIGHT GROIN PUNCTURE SITE. TWELVE HOURS LATER WHILE AT HOME THAT SAME DAY, THE PATIENT'S LEG BECAME COLD TO TOUCH AND PALE IN COLOR. THE EMERGENCY ROOM (ER) WAS CALLED AND THEY SUGGESTED THAT SHE CALL AN AMBULANCE AND COME DIRECTLY TO THE ER THAT NIGHT. SHE WENT TO THE ER THE NEXT MORNING, ON (B)(6) 2011 AND THE DEPLOYING PHYSICIAN ACCESSED THE LEG, DID NO FURTHER TESTS AND SENT HER HOME. THE PATIENT CONTACTED HER VASCULAR SURGEON AND WAS SEEN ON (B)(6) 2011 BY THE SURGEON'S OFFICE AND AN ULTRASOUND WAS PERFORMED WHICH REVEALED A RIGHT LEG VESSEL BLOCKAGE. ON (B)(6) 2011, THE PATIENT UNDERWENT AN ANGIOGRAM AND THE PATIENT'S BLOOD FLOW IN THE RIGHT LEG WAS DIAGNOSED TO BE 4%, A DECREASE FROM A (B)(6) 2010 ASSESSMENT OF 98%. SURGERY WAS PERFORMED WHERE THE ANGIO-SEAL WAS REMOVED AND THE ARTERY WAS CLEANED OUT. THE PATIENT SPENT TWO DAYS RECOVERING IN THE HOSPITAL AND IS REPORTED TO BE WELL AND RECOVERING AT HOME. THE PATIENT IS A SMOKER AND HAS A MEDICAL HISTORY OF LEFT LEG PERIPHERAL VASCULAR DISEASE. THE PATIENT STATED THAT THE SURGEON ALLEGED THAT THE BLOCKAGE WAS CAUSE FROM THE ANGIO-SEAL. MULTIPLE ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION WITHOUT SUCCESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R