BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6 FR. SMC SYSTEM

    MDR report key: 591148 · Received April 12, 2005

    Report

    Report Number
    2953144-2005-00038
    Event Type
    Injury
    Date Received
    April 12, 2005
    Date of Event
    March 8, 2005
    Report Date
    March 15, 2005
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTED DUE TO STENOSIS. THE PHYSICIAN SUCCESSFULLY CLOSED AN ARTERITOMY SITE WITH THE PERCLOSE PROGLIDE DEVICE FOLLOWING A CEREBRAL INTERVENTIONAL PROCEDURE. REPORTEDLY, A "DOUBLE-SIDED" PROCEDURE WAS PERFORMED, USNG THE PROGLIDE DEVICE IN THE RIGHT COMMON FEMORAL ARTERY AND AN ANGIOSEAL DEVICE IN THE LEFT COMMON FEMORAL ARTERY. FLUOROSCOPY WAS PERFORMED PRIOR TO THE PROCEDURE AND THE VESSEL, APPEARED TO BE FINE AT THE TIME." REPORTEDLY, THERE WAS "SLIGHT RESISTANCE" WITH THE INITIAL INSERTION OF THE PROGLIDE DEVICE, HOWEVER, CLOSURE WAS ACHIEVED WITHOUT ANU ISSUES. APPROXIMATELY, FOUR (4) TO FIVE (5) DAYS FOLLOWING THE PROCEDURE, THE PT PRESENTED TO THE HOSP WITH COMPLAINTS OF RIGHT LEG CLAUDICATION AND PULSELESSNESS. AN ULTRASOUND OF THE RIGHT LEG WAS PERFORMED AND WAS POSITIVE FOR STENOSIS. AT LAST REPORT, THE PT WAS AWAITING SURGERY. ALTHOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE.

    Description of Event or Problem · 1

    IN 03/2005, THE PT PRESENTED TO THE VASCULAR SURGEON WITH RIGHT CALF CLAUDICATION AND NO PULSES DISTAL TO THE RIGHT GROIN. ELEVAN DAYS LATER, AN ANGIOGRAM SHOWED "DIFFUSE NARROWING OF 50% IN CFA (COMMON FEMORAL ARTERY) FOLLOWED BY A FOCAL FILLING DEFECT WITH CONTRAST CHANNELS ON EACH SIDE; NO EMBOLI." TWO DAYS LATER, THE PT HAD SURGERY WHERE AN "ENDARTERECTOMY AND PATCH" WAS PERFORMED. THE SURGERY SHOWED, "INTIMAL HYPERPLASIA ON THE POSTERIOR WALL AT THE SITE OF THE PUNCTURE; THE STITCH WAS APPARENTLY NOT THE CAUSE OF THE STENOSIS." THE CURRENT CONDITION OF THE PT IS UNKNOWN. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6 FR. SMC SYSTEM SUTURE MEDIATED CLOSURE MGB PERCLOSE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization AND HEPARIN FOR THE PROCEDURE.| THE PT WAS RECEIVING ASPIRIN, CLOPIDOGREL