BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3093871 · Received May 6, 2013

    Report

    Report Number
    2024168-2013-02790
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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 DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DIFFICULTY REMOVING THE DEVICE TO HARVEST THE SUTURE WAS CONFIRMED. BASED ON VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT-HANDLING DATABASE FROM THIS LOT INDICATED DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN INTERVENTIONAL PROCEDURE, ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE. THE DEVICE WAS PREPARED FOR USE AS INDICATED IN THE INSTRUCTIONS FOR USE. DEVICE DEPLOYMENT OCCURRED THROUGH A 7-FRENCH SIZED ACCESS SITE. REPORTEDLY, AFTER RETRACTING THE FOOT, SIGNIFICANT RESISTANCE WAS ENCOUNTERED WITHDRAWING THE DEVICE BACK TO HARVEST THE SUTURE. THE DEVICE WAS REMOVED AND THE SUTURE OF A SECOND PROGLIDE DEVICE WAS DEPLOYED AND USED TO ACHIEVE HEMOSTASIS AFTER COMPLETION OF THE INTERVENTIONAL PROCEDURE. THE PROCEDURE WAS PERFORMED UNDER LOCAL ANESTHESIA. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE IN-TRAINING IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: IT WAS REPORTED THAT PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, PRE-CLOSE PLACEMENT OF THE SUTURES WAS ATTEMPTED OF THE RIGHT COMMON FEMORAL ARTERY USING PERCLOSE PROGLIDE DEVICES. THE DEVICE WAS PREPARED FOR USE AS INDICATED IN THE INSTRUCTIONS FOR USE. THE DEVICES WERE DEPLOYED THROUGH A 7-FRENCH SIZED ACCESS SITE. THE FIRST PROGLIDE DEVICE SUTURE WAS SUCCESSFULLY DEPLOYED. REPORTEDLY, DURING DEPLOYMENT OF THE SECOND PROGLIDE DEVICE AFTER RETRACTING THE FOOT, SIGNIFICANT RESISTANCE WAS ENCOUNTERED WITHDRAWING THE DEVICE BACK TO HARVEST THE SUTURE RESULTING IN UNSUCCESSFUL SUTURE DEPLOYMENT. THE DEVICE WAS REMOVED AND THE SUTURE OF A THIRD PROGLIDE DEVICE WAS DEPLOYED. THE SUTURES WERE SET TO THE SIDE AND THE ACCESS SITE WAS UPSIZED TO ACCOMMODATE A 22-FRENCH SHEATH. AFTER CONCLUSION OF THE TAVI PROCEDURE, THE KNOTS OF THE TWO PROGLIDE DEVICES WERE SEQUENTIALLY ADVANCED AND TIGHTENED TO ACHIEVE HEMOSTASIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196763 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30123J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 7-FRENCH| SHEATH: 22-FRENCH