BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA PZF

    MDR report key: 8197438 · Received December 26, 2018

    Report

    Report Number
    3009306400-2018-00082
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Date of Event
    November 30, 2018
    Report Date
    December 26, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397000678
    PMA / PMN Number
    160014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY CELONOVA BIOSCIENCES ON 13-DEC-2018. DEVICE ANALYSIS IS NOT YET COMPLETE. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCE'S. THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS, INCLUDING FOR STENT RETENTION. STENT DAMAGE AND DISLODGEMENT ARE CAPTURED IN THE RISK ASSESSMENT AS KNOWN POTENTIAL HAZARDS. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WITH RELEVANT ADDITIONAL INFORMATION WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, WHILE PREPPING A 2.5X15MM, COBRA PZF NANOCOATED CORONARY STENT SYSTEM FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE STENT CAME OFF OF THE BALLOON AND STENT DAMAGE WAS NOTED (THE STENT STRUTS APPEARED TO BE MANGLED). THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035002 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1802124001 00879397000678

    Patients

    Seq Age Sex Outcome Treatment
    1