BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2132727 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04302
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. WITHOUT THE PRODUCT TO EXAMINE, NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE REPORTED INCIDENT. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO AN INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. THE LOT NUMBER IS UNKNOWN BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE LOT NUMBER WAS NOT REPORTED. BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT, THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF AN ISSUE WITH THE QUALITY OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A LEFT HEART CATHETERIZATION PROCEDURE. REPORTEDLY, AFTER THE DEVICE WAS DEPLOYED, HEMOSTASIS WAS ACHIEVED. TWO DAYS LATER ((B)(6) 2011), THE PATIENT REPORTED PAIN IN THE LEG. AN ANGIOGRAM WAS TAKEN WHICH SHOWED THAT AN OCCLUSION HAD FORMED IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY. THE PATIENT WAS REFERRED TO A VASCULAR SURGEON FOR TREATMENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention