BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2251340 · Received September 16, 2011

    Report

    Report Number
    2024168-2011-06359
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    October 27, 2010
    Report Date
    August 26, 2011
    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). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THE WHOLE MONOFILAMENT WAS RETURNED LOOSE WITH THE NEEDLE TIP STILL ATTACHED TO THE RAIL END. THE ANTERIOR CUFF WAS ENGAGED TO ANTERIOR NEEDLE TIP AND BOTH CUFFS WERE ATTACHED TO THE LINK. THE POSTERIOR CUFF WAS OUT OF THE POCKET AND THE POSTERIOR CUFF TABS WERE UNDISTURBED, INDICATING THAT A POSTERIOR CUFF MISS OCCURRED. CONTRIBUTING FACTORS FOR NEEDLE DEFLECTION THAT RESULTED IN THE POSTERIOR CUFF MISS INCLUDED, BUT NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND DEPLOYMENT TECHNIQUES. BASED ON THE SUCCESSFUL TEST OF THE DEVICE NEEDLE TRAJECTORY IN THE LAB AND DURING MANUFACTURING, 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. IT WAS REPORTED THAT THE COMMON FEMORAL ARTERY WAS MODERATELY CALCIFIED AND THIS COULD BE A CONTRIBUTING FACTOR FOR THE CUFF MISS. PER INSTRUCTIONS FOR USE (IFU) FOR PROGLIDE UNDER SPECIAL PATIENT POPULATIONS STATES THAT THE SAFETY AND EFFECTIVENESS OF PROGLIDE HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. BASED ON THE RESULTS OF THE INVESTIGATION, THE PROBABLE CAUSE WAS DETERMINED TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE DEVICE AND NOT A PRODUCT QUALITY DEFICIENCY. REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE DOES NOT APPEAR TO BE AN INDICATION OF A PRODUCT QUALITY PROBLEM.

    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 REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PROGLIDES ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHEN THE PLASTIC PART WAS PULLED, THE PROLENE SUTURE WAS NOT ATTACHED TO THE METAL SHAFT, CLOSURE COULD NOT BE COMPLETED. THE SAME RESULTS OCCURRED WITH ALL THREE UNITS. AN UNKNOWN CLOSURE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. 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.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED. A PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS.

    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 890136H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN