BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 116208 · Received August 28, 1997

    Report

    Report Number
    3014398-1997-00100
    Event Type
    Injury
    Date Received
    August 28, 1997
    Date of Event
    June 18, 1997
    Report Date
    August 1, 1997
    Manufacturer
    QUINTON INSTRUMENT CO.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A DIAGNOSTIC PROCEDURE, AN ANGIO-SEAL DEVICE WAS PLACED. THE NEXT DAY, THE PATIENT COMPLAINED OF PAIN. AN ULTRASOUND WAS PERFORMED WHICH REVEALED NOTHING UNUSUAL. APPROXIMATELY 2-3 WEEKS FOLLOWING DEPLOYMENT, THE PATIENT DEVELOPED SUDDEN ACUTE SWELLING IN THE GROIN SITE WITH RUPTURE TO THE SURFACE AND SOME BLEEDING FROM THE SITE. UPON FOLLOW-UP WITH HIS PHYSICIAN, A HEMATOMA WAS DRAINED. FOLLOWING THE TREATMENT FOR THE HEMATOMA, THE WOUND SITE CONTINUED TO DRAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FURTHER WORKUP AND TREATMENT OF A CATHETER SITE INFECTION AND PROBABLE VASCULITIS. THE PHYSICAL EXAM WAS UNREMARKABLE EXCEPT FOR A RIGHT GROIN PUNCTURE SITE WHICH WAS RED AND WARM WITH AN AREA OF ERYTHEMA MEASURING APPROXIMATELY 2.5X1.5 CM SURROUNDING THE PUNCTURE SITE. THERE WAS SEROANGUINEOUS DRAINAGE FROM THE SITE WHICH WAS TENDER TO PALPATION. THERE WAS ALSO A FIRM 2 CM MASS PALPABLE AT THE SITE. THE PATIENT WAS STARTED ON VANCOMYCIN (1 GM IV EVERY 12 HOURS). SURGICAL EXPLORATION WAS PERFORMED ON 07/02/1997; THE ANGIO-SEAL WAS FOUND TO BE EXTRUDED OUT INTO THE SUBCUTANEOUS TISSUE. CULTURES WERE OBTAINED, AND MINIMAL PURULENT DRAINAGE FROM THE AREA WAS NOTED. THE ANTERIOR WALL OF THE COMMON FEMORAL ARTERY WAS DAMAGED; THIS WAS EXCISED (APPROX. 3CM) AND REQUIRED A SAPHENOUS VEIN PATCH GRAFT. THE WOUND WAS IRRIGATED WITH ANTIBOTIC SOLUTION AND NORMAL SALINE, AND CLOSED IN A NORMAL FASHION WITH PLACEMENT OF A JACKSON-PRATT DRAIN. IN THE IMMEDIATE POSTOPERATIVE COURSE, THE PATIENT EXPERIENCED RESPIRATORY DISTRESS REQUIRING REINTUBATION AND DEVELOPED CONGESTIVE HEART FAILURE. THE PATIENT WAS KEPT IN ICU FOR 24 HOURS. THE NEXT DAY THE PATIENT WAS EXTUBATED WITHOUT DIFFICULTY. THE PATIENT CONTINUED TO IMPROVE RAPIDLY, AND ON POST-OP DAY 2 WAS STABLE WITHOUT COMPLAINTS OTHER THAN SOME PAIN AT THE SITE. ON POST-OP DAY 4 THE WOUND WAS CONTINUING TO IMPROVE WITH NO SIGNS OF NEW INFECTION. ON POST-OP DAY 5, THE PATIENT WAS DISCHARGED WITHOUT FURTHER SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL Implant HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB QUINTON INSTRUMENT CO. NA 800736

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R