BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1040593 · Received May 9, 2008

    Report

    Report Number
    3003681312-2008-00041
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 11, 2008
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP MEDWATCH WILL BE SUBMITTED AT THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A PERCUTANEOUS CORONARY PROCEDURE A 6F ANGIO-SEAL VIP WAS DEPLOYED. IMMEDIATELY AFTER DEPLOYMENT, BLOOD CONTINUED LEAKING FROM THE PUNCTURE SITE. LIGHT COMPRESSION WAS APPLIED FOR 2 TO 3 MINUTES. UPON TRANSFER TO THE CART THE RIGHT LEG APPEARED WHITER IN COLOR. THE PATIENT WAS QUESTIONED REGARDING THIS AND THE PATIENT STATED PREVIOUS PROBLEMS WITH THE FOOT. EVEN THOUGH THE RIGHT LEG BELOW THE KNEE WAS PALER IN COLOR, THERE WERE PALPABLE PEDAL PULSES AND THE LEG WAS WARM TO THE TOUCH AND THE SAME AS THE LEFT LEG. DURING TRANSFER TO THE FLOOR 30 MINUTES LATER, THE PATIENT COMPLAINED OF DORSAL RIGHT FOOT PAIN AND A CRAMP-LIKE PAIN FROM THE RIGHT KNEE TO ANKLE. THE RIGHT LEG BELOW THE KNEE WAS NOW WHITER IN COLOR TO THE LEFT LEG AND COLDER TO THE TOUCH. THERE WAS ALSO A DISTINCT DIFFERENCE BETWEEN THE RIGHT LEG FROM THE HIP AND KNEE AREAS. A VASCULAR SURGEON WAS CONSULTED. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO RESTORE BLOOD FLOW. THE ANGIO-SEAL WAS REMOVED. ALLEGEDLY THE PHYSICIAN DID NOT PERFORM A PRE-DEPLOYMENT FEMORAL ANGIOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 2056266

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention