BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2926278 · Received January 15, 2013

    Report

    Report Number
    3003681312-2013-00002
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 31, 2012
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT WAS NOT RETURNED, OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE FOR A PUNCTURE IN THE RIGHT FEMORAL ARTERY FOLLOWING A PRE-DEPLOYMENT ANGIOGRAM, DETERMINING THAT THE VESSEL WAS SUITABLE FOR DEPLOYMENT. THE 6F INTRODUCER WAS REMOVED AND THE DEVICE WAS SUCCESSFULLY DEPLOYED, ACHIEVING HEMOSTASIS. DIMINISHED PULSES WERE NOTED AND THE PATIENT REPORTED NUMBNESS, WHICH WAS ATTRIBUTED TO THE LIDOCAINE. DURING OBSERVATION, THE LEG BECAME PALPABLY COOL, AND DOPPLER REVEALED VASCULAR INSUFFICIENCY. AN ANGIOGRAM CONFIRMED THAT THERE WAS ACUTE CLOSURE AT THE SITE AND AN ANGIOPLASTY WAS DONE TO REESTABLISH FLOW. THE OCCLUSION DID NOT APPEAR TO BE THROMBUS OR COLLAGEN, BUT THAT SUTURE WAS HOLDING THE OPPOSING SIDES OF THE VESSEL WALL TOGETHER. THE PATIENT WAS ADMITTED FOR THE INTERVENTION AND DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22632 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 3837276

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R ASPIRIN (UNK DOSE/STRENGTH)| EFFIENT (UNK DOSE/STRENGTH)