BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2213497 · Received August 16, 2011

    Report

    Report Number
    2024168-2011-05768
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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 OTHER PERCLOSE PROGLIDE DEVICE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THAT THE WHOLE MONOFILAMENT WAS LOOSE AND THE NEEDLE TIP WAS STILL ATTACHED TO THE RAIL END. THE PLUNGER, CUFFS AND LINK WERE NOT RETURNED, LIMITING THE SCOPE OF THIS INVESTIGATION. BASED ON THE INVESTIGATION FINDINGS, A POSTERIOR CUFF MISS OCCURRED BECAUSE THE NEEDLE TIP WAS RETURNED WITHOUT THE POSTERIOR CUFF AND THIS CONFIRMED THE REPORTED EVENT. THE USE OF AN ADDITIONAL DEVICE AND/OR MANUAL COMPRESSION IS CONSIDERED NON-SURGICAL TREATMENT OR THERAPY TO ACHIEVE HEMOSTASIS. CONTRIBUTING FACTORS FOR NEEDLE DEFLECTION THAT RESULTED IN THE POSTERIOR CUFF MISS CAN INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND DEPLOYMENT TECHNIQUES. DURING INVESTIGATION, A PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND THE RESULTS MET THE MANUFACTURING CRITERIA. THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE TO SUGGEST INCORRECT TECHNIQUE. BASED ON THE SUCCESSFUL TEST OF THE NEEDLE TRAJECTORY, THE PROBABLE CAUSE FOR THE POSTERIOR CUFF MISS IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE OR FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREES ANGLE THROUGHOUT DEPLOYMENT. THERE WAS NO MANUFACTURING OR QUALITY DEFICIENCY DETECTED THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. REVIEW OF THE LOT HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED DURING MANUFACTURING AND A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A PROGLIDE DEVICE VIA A 6 FR SHEATH, AFTER A DIAGNOSTIC LEFT HEART CATHERIZATION. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED, NO SUTURE WAS PRESENT. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING MANUAL ARTERIAL COMPRESSION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE 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 030186H

    Patients

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