BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 120911 · Received September 17, 1997

    Report

    Report Number
    3014398-1997-00115
    Event Type
    Injury
    Date Received
    September 17, 1997
    Date of Event
    August 15, 1997
    Report Date
    August 18, 1997
    Manufacturer
    QUINTON INSTRUMENT CO.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A DIAGNOSTIC PROCEDURE ON 08/12/1997, AN ANGIO-SEAL DEVICE WAS DEPLOYED. HOWEVER, ON 08/15/1997, THE PT COMPLAINED OF CLAUDICATION WHICH PRESENTED AS A CRAMP WHICH THEN PROGRESSED UPWARD INTO HIS RIGHT BUTTOCK. ON 08/19/1997 THE PT SAW HIS PHYSICIAN AND AN ULTRASOUND WAS PERFORMED. THE ULTRASOUND SHOWED A 95% BLOCKAGE BY A POSTERIOR THROMBUS. ON 08/20/1997 THE PHYSICIAN DECIDED TO POSTPONE SURGICAL ASSESSMENT/INTERVENTION UNTIL THE PT WENT IN FOR HIS PREVIOUSLY SCHEDULED OPEN HEART PROCEDURE. ON 08/26/1997 FOLLOW-UP, IT WAS LEARNED THAT THE PT WAS PLACED ON COUMADIN WITH RESOLUTION OF THE CLAUDICATION SYMPTOMS. FOLLOW-UP WITH THE PT ON 09/15/1997 DETERMINED THAT THE ANGIO-SEAL DEVICE WAS SURGICALLY REMOVED ON 09/03/1997 CONCURRENTLY WITH THE PREVIOUSLY SCHEDULED CORONARY ARTERY BYPASS SURGERY, WITH IMMEDIATE RESOLUTION OF CLAUDICATION AND NO FURTHER DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL Implant HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB QUINTON INSTRUMENT CO. NA 800801

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention