BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3210587 · Received July 8, 2013

    Report

    Report Number
    2024168-2013-04259
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 4, 2011
    Report Date
    June 14, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED NEEDLE-TO-CUFF MISS WAS NOT CONFIRMED. ANALYSIS OF THE DEVICE INDICATED THE NEEDLE PLUNGER WAS PULLED OUT INSTEAD OF BEING DEPRESSED TO CAPTURE THE CUFFS. THE INSTRUCTIONS FOR USE STATES THE OPERATOR IS INSTRUCTED TO DEPLOY THE NEEDLES BY PUSHING ON THE PLUNGER ASSEMBLY (IN THE DIRECTION MARKED #2) UNTIL THE COLLAR OF THE PLUNGER MAKES CONTACT WITH THE PROXIMAL END OF THE DEVICE BODY. VISUALLY CONFIRM THAT THE COLLAR OF THE PLUNGER IS IN CONTACT WITH THE BODY OF THE DEVICE. DISENGAGE THE NEEDLES BY PULLING THE PLUNGER ASSEMBLY BACK (IN THE DIRECTION MARKED #3) AND COMPLETELY REMOVE THE PLUNGER AND NEEDLES FROM THE BODY OF THE DEVICE. BASED ON VISUAL INSPECTION AND FUNCTIONAL TESTING 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 AFTER AN UNSPECIFIED PROCEDURE, ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, A NEEDLE-TO-CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310039 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 830256H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention