BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 165554 · Received April 30, 1998

    Report

    Report Number
    3014398-1998-00129
    Event Type
    Injury
    Date Received
    April 30, 1998
    Date of Event
    March 27, 1998
    Report Date
    April 1, 1998
    Manufacturer
    QUINTON INSTRUMENT CO.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 3/26/1998 FOLLOWING A DIAGNOSITC PROCEDURE, AN ANGIO-SEAL DEVICE WAS PLACED IN A PT'S RIGHT GROIN. THE PT WAS DISCHARGED HOME THAT DAY. LATER THAT SAME EVENING THE PT EXPERIENCED PAIN IN HER PROCEDURE LEG. THREE DAYS LATER (3/29/1998) THE PT EXPERIENCED NUMBNESS IN HER PROCEDURE LEG. ON 4/1/1998 THE PT UNDERWENT A DOPPLER STUDY AND AN ANGIOGRAM WHICH IDENTIFIED AN OCCLUSION OF THE RIGHT COMMON FEMORAL ARTERY. ON 4/2/1998 THE PT WAS TAKEN TO SURGERY, WHERE THE DEVICE COLLAGEN WAS FOUND TO BE OCCLUDING THE VESSEL. THE DEVICE COLLAGEN AND SUTURE WERE REMOVED FROM THE ARTERY. FOLLOWING THIS ACTION, A LARGE THROMBUS AND PLATELET PLUG WERE OBSERVED AND ALSO REMOVED. AN INFLAMMATORY REACTION OF THE ARTERIAL WALL WAS NOTED. PATCH ANGIOPLASTY OF THE COMMON FEMORAL ARTERY WAS PERFORMED WITH FLOW RESTORED. FOLLOW-UP ON 4/6/1998 CONFIRMS THAT THE PT WAS DISCHARGED HOME IN GOOD CONDITION. AS OF 4/28/1998 THERE HAD BEEN NO FURTHER REPORT OF COMPLICATION OR PT SEQUELAE MADE TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL Implant HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB QUINTON INSTRUMENT CO. NA 801692

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention