BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA PZF

    MDR report key: 8261395 · Received January 18, 2019

    Report

    Report Number
    3009306400-2018-00089
    Event Type
    Malfunction
    Date Received
    January 18, 2019
    Date of Event
    December 21, 2018
    Report Date
    January 18, 2019
    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; ANALYSIS IS NOT YET COMPLETE. 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 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, PRIOR TO REMOVING A 4.0X18MM COBRA PZF NANOCOATED CORONARY STENT SYSTEM FROM ITS DISPENSER COIL PACKAGING, THE COIL WAS FLUSHED WITH HEPARINIZED SALINE. THE STENT SYSTEM WAS THEN PULLED OUT OF THE COIL WITHOUT DIFFICULTY. NEGATIVE PRESSURE, WITH CONTRAST, WAS THEN DRAWN USING AN INDEFLATOR INFLATION DEVICE, FOLLOWED BY REMOVAL OF THE PROTECTIVE STENT SHEATH, WITHOUT ISSUE. THE STENT SYSTEM WAS THEN ADVANCED IN THE PATIENT VIA RADIAL ACCESS; ONCE CROSSING THE LESION, AN ATTEMPT WAS MADE TO DEPLOY THE STENT, BUT IT WAS DISCOVERED THAT THE STENT HAD DISLODGED ONTO THE PROXIMAL SHAFT AT SOME POINT DURING ADVANCEMENT. ALL DEVICES (STENT, DELIVERY SYSTEM, GUIDE CATHETER, AND GUIDE WIRE) WERE THEN WITHDRAWN AS A SINGLE UNIT. THE FLARED STENT ENDS WERE THEN NOTED AND, REPORTEDLY, THE FLARED ENDS LIKELY OCCURRED DURING ADVANCEMENT THEN WITHDRAWAL. THERE WERE NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS SUCCESSFULLY TREATED WITH A DRUG-ELUTING STENT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55324 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1711024001 00879397000678

    Patients

    Seq Age Sex Outcome Treatment
    1