BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2941010 · Received February 4, 2013

    Report

    Report Number
    2024168-2013-00593
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    December 5, 2012
    Report Date
    January 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. ESTIMATED DATE OF OCCURRENCE, EXACT DATE WAS WITHIN THE LAST TWO MONTHS. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS NOT CONFIRMED. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SUTURE AND THE POSTERIOR CUFF WERE NOT RETURNED WITH THE DEVICE. THE PLUNGER WAS OUTSIDE OF THE HANDLE AND WAS ATTACHED TO A LINK. THE POSTERIOR LINK WAS NOT ATTACHED TO A CUFF. THE POSTERIOR LINK WAS EXAMINED AND IT SHOWED SIGNS OF TEARING AND SHEARING. THE HANDLE WAS EXAMINED AND IT WAS NORMAL. THE FOOT ACTUATED AS INTENDED AND WAS NOT DAMAGED. THESE OBSERVATIONS WOULD INDICATE THAT THE SUTURE ASSEMBLY SNAGGED/STALLED DURING PLUNGER WITHDRAW RESULTING IN FORCE NEEDED TO WITHDRAW THE PLUNGER FULLY AND BROKE THE LINK AT THE POSTERIOR CUFF. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER CARDIAC CATHETERIZATION PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46208 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21009J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention