BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20/30 PRIORITY PACK W/COPILOT

    MDR report key: 3881858 · Received June 18, 2014

    Report

    Report Number
    2024168-2014-03906
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 21, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAV
    PMA / PMN Number
    K961471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND THE REPORTED RESISTANCE DURING REMOVAL WAS NOT ABLE TO BE CONFIRMED. THE CAP WAS REMOVED AND THE BLEED BACK CONTROL SEAL (BBC) WERE CHECKED. THE BBC SEAL WAS TORN. BASED ON A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED AND THE PACKAGING WAS NOT RETURNED. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UN-SPECIFIED CORONARY LESION. AN UNKNOWN STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT COULD NOT CROSS DUE TO THE ANATOMY. DURING REMOVAL, RESISTANCE WAS MET WITH THE COPILOT DEVICE, AND THE STENT BECAME STRIPPED OFF, IN THE COPILOT. THE DEVICES WERE REMOVED AS A SINGLE UNIT, AND NEW DEVICES WERE USED TO COMPLETE THE PROCEDURE. THIS OCCURRED WITH THREE COPILOT DEVICES DURING THIS PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICES WERE RETURNED. ANALYSIS OF ONE OF THE DEVICES FOUND THAT THE BLEED BACK CONTROL SEAL (BBC) WAS TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357204 20/30 PRIORITY PACK W/COPILOT ACCESSORY KIT MAV AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1