BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1083441 · Received July 29, 2008

    Report

    Report Number
    2953144-2008-01248
    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: ACCESS SITE INFECTION TREATED WITH INCISION AND DRAINAGE. TIME OF SYMPTOMS/AE: 7 DAYS AFTER VESSEL CLOSURE. THE FOLLOWING EVENT WAS NOTED THROUGH A PERIODIC ARTICLE REVIEW THT 1004 PTS UNDERWENT PERCUTANEOUS CORONARY INTERVENTIONS FOLLOWED BY ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WITH A PROSTAR DEVICE. THE PT WITH UNSTABLE ANGINA UNDERWENT A ROTATIONAL ATHERECTOMY AND ANGIOPLASTY; VESSEL CLOSURE WAS ACHIEVED WITH AN 8FR PROSTAR DEVICE. FOUR DAYS LATER, THE PT DEVELOPED GROIN PAIN, BUT DID NOT SEEK MEDICAL ATTENTION FOR ANOTHER THREE DAYS; THE PT BECAME FEBRILE. PHYSICAL EXAM REVEALED A TENDER GROIN MASS AND THE WOUND WAS EXPLORED. THE ABSCESS AT THE CLOSURE SITE WAS CAUSED BY S. EPIDERMIDIS, S. AUREUS AND K. PNEUMONIAE; THE TREATMENT CONSISTED OF INCISION AND DRAINAGE. THE PT REMAINED HOSPITALIZED FOR THREE DAYS AND WAS DISCHARGED WITH ANTIBIOTIC THERAPY FOR TEN DAYS. THE PT WAS REPORTED TO BE ALIVE AND WELL 13 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 73 YR Hospitalization| R SHEATH: 10FR