BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3021397 · Received March 26, 2013

    Report

    Report Number
    2024168-2013-01720
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 4, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROGLIDE DEVICE WAS RETURNED FOR EVALUATION. THE SUTURE TRIMMER, PLUNGER, SUTURE, LINK, NEEDLES AND CUFFS WERE NOT RETURNED WITH THE PROGLIDE DEVICE. THE REPORTED FAILURE TO CUT THE SUTURE WITH A SUTURE TRIMMER COULD NOT BE CONFIRMED AND A DEFINITIVE CAUSE COULD NOT BE IDENTIFIED BECAUSE THE SUTURE TRIMMER WAS NOT RETURNED FOR INVESTIGATION. 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. TWO UNUSED REPRESENTATIVE SAMPLES WITH THE SAME LOT NUMBER AS THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICES PERFORMED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WAS ACHIEVED USING A PROGLIDE WITH A 6FR SHEATH, AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE PROGLIDE DEVICE DELIVERED THE SUTURE AND ONCE THE DEVICE WAS REMOVED THE SUTURE TRIMMER WAS PLACED ON THE SUTURE AND INTO THE PUNCTURE TRACT. THE KNOT WAS PUSHED DOWN AND TIGHTENED, HEMOSTATIS WAS OBTAINED, AND THE WIRE REMOVED. THE KNOT WAS LOCKED AND THE DOCTOR PULLED THE RED LEVER TO CUT THE SUTURE, THE RED LEVEL WENT FLOPPY AND FLAPPED AROUND, IT WOULD NOT RELEASE FROM THE SUTURE AND WOULD NOT CUT. AFTER 5-10 MINUTES OF TWISTING AND TRYING TO GET THE LEVER TO RELEASE, THE SPRING ON THE RED LEVER SEEMED TO RELEASE AND THE SUTURE TRIMMER WAS REMOVED, WITHOUT CUTTING THE SUTURE. A SECOND SUTURE TRIMMER WAS USED TO CUT THE SUTURES. HEMOSTASIS WAS ACHIEVE WITH THE PROGLIDE DEVICE. 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
    122943 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20623J1

    Patients

    Seq Age Sex Outcome Treatment
    1 SHEATH: 6FR