BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 185244 · Received September 3, 1998

    Report

    Report Number
    3032312-1998-00130
    Event Type
    Injury
    Date Received
    September 3, 1998
    Date of Event
    April 2, 1998
    Report Date
    April 2, 1998
    Manufacturer
    THE KENDALL CO
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 03/09/1998 FOLLOWING A PTCA/STENT PROCEDURE, AN ANGLO-SEAL DEVICE WAS PLACED IN A PT'S RIGHT GROIN. FOLLOWING DEPLOYMENT BLEEDING WAS NOTED AT THE PUNCTURE SITE. MANUAL PRESSURE AND A FEMOSTOP WERE APPLIED WITH CONTROL OF THE BLEEDING. THE PT LATER DEVELOPED SYMPTOMS OF CLAUDICATION (DATE OF ONSET UNK). ON 04/02/1998 AN ANGIOGRAM WAS PERFORMED WHICH FOUND A DISSECTION PLAIN TO THE RIGHT FEMORAL ARTERY. THE PT WAS TAKEN TO SURGERY AND THE VESSEL WAS REPAIRED. AS OF 09/02/1998 THERE HAS BEEN NO FURTHER REPORT TO THE MFR OF COMPLICATION OR PT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL Implant HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB THE KENDALL CO NA 801625

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention