BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2171812 · Received July 22, 2011

    Report

    Report Number
    2024168-2011-05080
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REPORTED TO HAVE BEEN DISCARDED. WITHOUT THE DEVICE EVALUATION, A CAUSE FOR THE REPORTED CUFF MISS COULD NOT BE DETERMINED. A CUFF MISS CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING ISSUES, USER TECHNIQUE, OR PATIENT ANATOMY. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED DURING MANUFACTURING. IN ADDITION, A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND / OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL CAN BE CONTRIBUTING FACTORS. HOWEVER, INFORMATION IN REGARDS TO THE USER TECHNIQUE WAS NOT PROVIDED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS THAT WOULD HAVE AFFECTED THE REPORTED NEEDLE TO CUFF MISS EVENT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND NO PRODUCT QUALITY DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE FIRST PERCLOSE PROGLIDE DEVICE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. 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 COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. ANOTHER PROGLIDE WAS USED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING A THIRD PROGLIDE DEVICE. THERE WAS NO ADVERSE PATIENT SEQUELA. REPORTEDLY, THE PHYSICIAN IS TRAINED IN THE USE OF THE DEVICE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 030336H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F