BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 4252050 · Received November 14, 2014

    Report

    Report Number
    2024168-2014-07470
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 23, 2014
    Report Date
    October 23, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE FEMORAL ANGIOGRAM REVEALED CALCIFICATION AT THE RIGHT COMMON FEMORAL ARTERY ACCESS SITE. THE INSTRUCTIONS FOR USE STATE UNDER SPECIAL PATIENT POPULATIONS THAT THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN PATIENT POPULATIONS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED, BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A CAROTID VALVE REPLACEMENT, PRE-CLOSE PLACEMENT OF THE SUTURES WAS ATTEMPTED IN A CALCIFIED RIGHT COMMON FEMORAL ARTERY THROUGH A 6-FRENCH ACCESS SITE USING PERCLOSE PROGLIDE DEVICES. REPORTEDLY, AFTER SUCCESSFULLY DEPLOYING THE SUTURE OF THE FIRST PROGLIDE DEVICE, AN ATTEMPT WAS MADE TO DEPLOY THE SUTURE OF A SECOND PROGLIDE DEVICE, BUT A NEEDLE-TO-CUFF MISS OCCURRED. THE DEVICE WAS REMOVED AND THE SUTURE OF A THIRD PROGLIDE DEVICE WAS DEPLOYED. THE SUTURES OF BOTH DEVICES WERE TAPED TO THE SIDE AND THE ACCESS SITE WAS UPSIZED TO AN UNSPECIFIED SIZE. AFTER THE CAROTID VALVE REPLACEMENT, THE KNOTS FROM THE FIRST AND THIRD PROGLIDE DEVICES WERE ADVANCED AND TIGHTENED TO ACHIEVE HEMOSTASIS. ACCESS SITE OOZING WAS PRESENT AND TREATED WITH TWO TO THREE MINUTES OF DIGITAL ADJUNCTIVE COMPRESSION. IN ADDITION, THE PATIENT WAS INFUSED WITH PROTAMINE TO REVERSE THE EFFECTS OF THE HEPARIN. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROGLIDE DEVICE AND ESTABLISHED IN THE PRE-CLOSE DEPLOYMENT TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736615 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention SHEATH: 6-FRENCH HEPARIN, PROTAMINE