BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 4060551 · Received September 4, 2014

    Report

    Report Number
    2024168-2014-05674
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    November 1, 2007
    Report Date
    July 25, 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. DATE OF OCCURRENCE IS ENTERED AS (B)(6) 2007 AS THE PROCEDURES OCCURRED BETWEEN NOVEMBER 2007 AND MAY 2012. FAILURE TO FOLLOW STEPS/INSTRUCTIONS. THE PERCLOSE PROGLIDE SMC SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5F TO 21F SHEATHS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. LITERATURE ATTACHMENT: MAMOO NAKAMURA; TARUN CHAKRAVARTY; HASAN JILAIHAWI; NIRAJ DOCTOR; SUHAIL DOHAD; GREGORY FONTANA; WEN CHENG; RAJ R. MAKKAR. (CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 2014; 84:293-300): COMPLETE PERCUTANEOUS APPROACH FOR ARTERIAL ACCESS IN TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT: A COMPARISON WITH SURGICAL CUT-DOWN AND CLOSURE.

    Additional Manufacturer Narrative · 1

    (B)(4). FAILURE TO FOLLOW STEPS/INSTRUCTIONS: IT WAS REPORTED THAT THE OPERATOR USED 22FR AND 24FR SHEATHS. THE PERCLOSE PROGLIDE INSTRUCTIONS FOR USE STATES, THE PERCLOSE PROGLIDE SMC SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5F TO 21F SHEATHS. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT A COMPLETE PERCUTANEOUS APPROACH USING THE PERCLOSE TECHNIQUE FOR ARTERIAL ACCESS/CLOSURE OF THE LEFT OR RIGHT COMMON FEMORAL ARTERY WAS PERFORMED USING TWO PERCLOSE PROGLIDE DEVICES. A TOTAL OF 140 PATIENTS RECEIVED THE PERCLOSE PROGLIDE BETWEEN NOVEMBER 2007 AND MAY 2012. OF THE 140 PATIENTS, CLINICAL OUTCOMES WERE INVESTIGATED IN 26 PATIENTS. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED, COMPLETE PERCUTANEOUS APPROACH FOR ARTERIAL ACCESS IN TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT: A COMPARISON WITH SURGICAL CUT-DOWN AND CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541086 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 22F, 24F