BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2122421 · Received June 13, 2011

    Report

    Report Number
    2024168-2011-04161
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 20, 2011
    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. THE OTHER PERCLOSE AT IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. WITHOUT DEVICE EVALUATION, A CAUSE FOR THE REPORTED LOSS OF LEG PULSE COULD NOT BE DETERMINED. HOWEVER, A LIKELY CONTRIBUTING CAUSE FOR LOSS OF PULSE IN THE LEG IS LOW OR LACK OF BLOOD FLOW. THIS CAN OCCUR WHEN A POSTERIOR WALL SUTURE PLACEMENT HAS TAKEN PLACE. THE PROGLIDE INSTRUCTION FOR USE (IFU) PROVIDES THE USER WITH STEPS BY WHICH A POSTERIOR SUTURE PLACEMENT CAN BE AVOIDED. IT IS NOT CLEAR WHETHER THE IFU REQUIREMENTS WERE ADHERED TO. BASED ON THE INFORMATION RECEIVED, THERE DOES NOT APPEAR TO BE ANY INDICATION OF AN ISSUE WITH THE QUALITY OF THE PRODUCT. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS NOT PERFORMED AS THE LOT NUMBER WAS NOT REPORTED AND THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PERCLOSE AT DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY, 5MM IN DIAMETER, AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER SUTURE DEPLOYMENT, THE SUTURES WERE NOT RETRIEVED. THE DEVICE WAS REWIRED AND REMOVED. A SECOND AT DEVICE WAS DEPLOYED. THE PATIENT LOST LEG PULSE AND WAS TAKEN TO SURGERY. ALTHOUGH ASKED, IT WAS NOT REPORTED WHAT CAUSED THE LEG PULSE LOSS. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention