BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA PZF

    MDR report key: 10393552 · Received August 11, 2020

    Report

    Report Number
    3009306400-2020-00022
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Date of Event
    July 16, 2020
    Report Date
    August 11, 2020
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397000883
    PMA / PMN Number
    P160014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED 23-JUL-2020. COMPLAINTS SPECIALIST PERFORMED APPLICABLE VISUAL AND DIMENSIONAL ANALYSIS ON THE RETURNED DEVICE. BLOOD WAS NOTED ON THE STENT (POSSIBLY DUE TO HANDLING WITH BLOODY GLOVES OR INSERTION THROUGH HEMOSTATIC VALVE, IF ATTEMPTED); STENT WAS DISLODGED, WITH EXTENSIVE STENT DAMAGE NOTED. COMPLAINTS SPECIALIST WAS UNABLE TO REPLICATE STENT DAMAGE AND DISLODGEMENT IN A TESTING ENVIRONMENT DUE TO THE CONDITION OF THE RETURNED DEVICE. 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. RISK ASSESSMENT REVIEW INDICATES THAT STENT DAMAGE AND DISLODGEMENT ARE CAPTURED AS KNOWN POTENTIAL OCCURRENCES. THOUGH UNABLE TO BE CONFIRMED, POTENTIAL CAUSES OF STENT DAMAGE AND DISLODGEMENT (BEFORE USE) MAY INCLUDE INADVERTENT ROUGH HANDLING DURING SHEATH REMOVAL AND/OR INTERACTION BETWEEN STENT AND HEMOSTATIC VALVE, IF INSERTION WAS ATTEMPTED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING; THERE IS NO EVIDENCE OF A DEVICE DEFICIENCY.

    Description of Event or Problem · 1

    ON (B)(6) 2020, WHILE UNPACKAGING A 3.5X30 COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM FOR A PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI), STENT DAMAGE WAS NOTED. ANOTHER 3.5X30 COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM WAS UNPACKAGED; STENT DAMAGE WAS ALSO OBSERVED ON THIS DEVICE AND THE STENT DISLODGED FROM THE BALLOON PRIOR TO ENTERING THE PATIENT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED BY THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857461 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 170-03-35030 1911114001 00879397000883

    Patients

    Seq Age Sex Outcome Treatment
    1