BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1083437 · Received July 29, 2008

    Report

    Report Number
    2953144-2008-01251
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    August 23, 2001
    Report Date
    July 15, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT INVOLVES A STUDY NOTED IN AN ARTICLE. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. THE PART AND LOT NUMBER WERE NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. ATTACHMENT: RANDOLPH L GEARY, MD, ET AL; "INFECTION IS AN UNUSUAL BUT SERIOUS COMPLICATION OF A FEMORAL ARTERY CATHETERIZATION SITE CLOSURE DEVICE". ANN VASC SURG 2001; 15:567-570.

    Description of Event or Problem · 1

    SYMPTOMS/AE: INFECTED ACCESS SITE PSEUDOANEURYSM TREATED WITH DEBRIDEMENT. TIME OF SYMPTOMS/AE: 7 DAYS AFTER VESSEL CLOSURE. THE FOLLOWING EVENT WAS NOTED THROUGH A PERIODIC ARTICLE REVIEW THAT 1004 PTS UNDERWENT PERCUTANEOUS CORONARY INTERVENTIONS FOLLOWED BY ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY (CFA) WITH A PROSTAR DEVICE. THE PT UNDERWENT A ROTATIONAL ATHERECTOMY AND ANGIOPLASTY; VESSEL CLOSURE WAS ACHIEVED WITH AN 8FR PROSTAR DEVICE. THE PT DEVELOPED PROGRESSIVE GROIN PAIN WITH A TENDER, NONCELLULITIC MASS AND, AFTER MULTIPLE EVALUATIONS IN AN EMERGENCY DEPARTMENT, WAS HOSPITALIZED. THE WOUND SPONTANEOUSLY DRAINED PUS AND AN INFECTED PSEUDOANEURYSM CAUSED BY S AUREUS WAS NOTED RESULTING IN DEBRIDEMENT OF THE CFA. THE PT REMAINED HOSPITALIZED FOR EIGHT DAYS AND WAS DISCHARGED WITH ANTIBIOTIC THERAPY FOR TWENTY-ONE DAYS. THE PT WAS REPORTED TO BE ALIVE AND WELL 20 MONTHS POST-PROCEDURE. THE ARTICLE DOES NOT DESCRIBE THE STERILE TECHNIQUE USED FOR THE VESSEL CLOSURE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE MGB ABBOTT VASCULAR REDWOOD CITY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R SHEATH: 9 FR