BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2180419 · Received July 27, 2011

    Report

    Report Number
    2024168-2011-05283
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT EXPERIENCE OCCURRED DURING AN ATTEMPT TO DEMONSTRATE DEVICE DEPLOYMENT USING AN ACRYLIC MODEL WITH LEATHER CHAMOIS TO SIMULATE THE VESSEL WALL. IT WAS REPORTED THAT DURING NEEDLE PLUNGER DEPLOYMENT, RESISTANCE WAS ENCOUNTERED, A CRUSHING SENSATION WAS FELT, AND NO SUTURE WAS PRESENT WHEN THE NEEDLE PLUNGER WAS REMOVED CONSISTENT WITH A NEEDLE-TO-CUFF MISS. THE CUSTOMER REPORTED THAT THE DEVICE WAS DISCARDED, WHICH MAY HAVE AIDED IN THE INVESTIGATION. IT IS LIKELY THAT THE REPORTED NEEDLE-TO-CUFF MISS WAS INFLUENCED BY THE TECHNIQUE OF THE USER SUCH AS A FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING NEEDLE PLUNGER DEPLOYMENT, AGGRESSIVELY DEPLOYING OR REMOVING THE NEEDLE PLUNGER, AND INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL. PATIENT ANATOMICAL CONDITIONS CAN ALSO INFLUENCE NEEDLE DEPLOYMENT; HOWEVER IN THIS CASE, THE DEVICE WAS DEPLOYED ON AN ACRYLIC MODEL WITH LEATHER CHAMOIS INSERTS AS A SIMULATED VESSEL; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURING IS ANOTHER POSSIBLE CAUSE; HOWEVER, THIS IS UNLIKELY SINCE EVERY DEVICE IS CHECKED TWICE DURING MANUFACTURING TO ENSURE PROPER NEEDLE TRAJECTORY. IT SHOULD BE NOTED THAT ALTHOUGH DURING NEEDLE PLUNGER DEPLOYMENT, RESISTANCE WAS ENCOUNTERED AND A CRUNCHING SENSATION WAS FELT, THE INSTRUCTIONS FOR USE STATE UNDER PRECAUTIONS TO NOT ADVANCE OR WITHDRAW THE PERCLOSE PROGLIDE SMC DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THAT RESISTANCE HAS BEEN DETERMINED AND EXCESSIVE FORCE USED TO ADVANCE OR TORQUE THE PERCLOSE PROGLIDE SMC DEVICE SHOULD BE AVOIDED, AS THIS MAY LEAD TO SIGNIFICANT VESSEL DAMAGE AND/OR BREAKAGE OF THE DEVICE. A REVIEW OF THE LOT HISTORY RECORD DID NOT REVEAL ANY RELEVANT NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS LOT. BASED ON THE INVESTIGATIONAL FINDING, THE REPORTED INCIDENT INFORMATION, AND MANUFACTURING RECORDS, A ROOT CAUSE FOR THE REPORTED NEEDLE-TO-CUFF MISS COULD NOT BE CONCLUSIVELY DETERMINED. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING AND A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE DEMONSTRATION ON AN ACRYLIC MODEL WITH LEATHER CHAMOIS INSERTS, PROGLIDE DEVICE DEPLOYMENT WAS ATTEMPTED. REPORTEDLY, DURING NEEDLE PLUNGER DEPLOYMENT, RESISTANCE WAS ENCOUNTERED WHEN THE NEEDLE PLUNGER WAS PUSHED AND A CRUNCHING SENSATION WAS FELT. WHEN THE NEEDLE PLUNGER WAS REMOVED, NO SUTURE WAS PRESENT. THERE WAS NO PATIENT INVOLVEMENT. 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 040466H

    Patients

    Seq Age Sex Outcome Treatment
    1