BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3230239 · Received July 16, 2013

    Report

    Report Number
    2024168-2013-04474
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 25, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER CORRECTION - LOT NUMBER CHANGED FROM 21003J1 TO 30416K1. THE DEVICE WAS RETURNED FOR EVALUATION. INSPECTION OF THE RETURNED DEVICE REVEALED THAT BOTH CUFFS SUCCESSFULLY CAPTURED THE NEEDLES AND THE RAIL SUTURE END WAS CUT WITH THE DEVICE CUTTER. THIS IS INDICATIVE OF SUCCESSFUL NEEDLE DEPLOYMENT AND SUTURE RETRIEVAL; THEREFORE, THE REPORTED CUFF MISS COULD NOT CONFIRMED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THE PROBABLE CAUSE WAS DETERMINED TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE DEVICE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE AFTER A CORONARY INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. MANUAL ARTERIAL COMPRESSION AND A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328591 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30416K1

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention SHEATH: 6F, HEPARIN