BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA PZF

    MDR report key: 8208138 · Received January 2, 2019

    Report

    Report Number
    3009306400-2018-00084
    Event Type
    Malfunction
    Date Received
    January 2, 2019
    Date of Event
    December 3, 2018
    Report Date
    January 2, 2019
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397000685
    PMA / PMN Number
    160014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE IS RETURNING, BUT HAS NOT YET BEEN RECEIVED BY CELONOVA BIOSCIENCES. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCES. THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS, INCLUDING FOR STENT RETENTION. STENT DISLODGEMENT IS CAPTURED IN THE RISK ASSESSMENT AS A KNOWN POTENTIAL HAZARD. 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, DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE FOR TREATMENT OF AN UNSPECIFIED CORONARY VESSEL, A 2.5X18MM, COBRA PZF NANOCOATED CORONARY STENT SYSTEM WAS ADVANCED THEN WAS WITHDRAWN, UNDEPLOYED, FOR AN UNSPECIFIED REASON. PRIOR TO ATTEMPTING RE-INSERTION OF THE STENT SYSTEM, THE PHYSICIAN NOTED THAT THE STENT HAD DISLODGED FROM THE STENT DELIVERY SYSTEM, OUTSIDE OF PATIENT ANATOMY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1712224001 00879397000685

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR