BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA PZF

    MDR report key: 9897942 · Received March 30, 2020

    Report

    Report Number
    3009306400-2020-00016
    Event Type
    Malfunction
    Date Received
    March 30, 2020
    Date of Event
    March 5, 2020
    Report Date
    April 15, 2020
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397000937
    PMA / PMN Number
    P160014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ATTACHMENT: [B)(4)].

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL FILED MEDWATCH REPORT, USER FACILITY MEDWATCH REPORT WAS RECEIVED AND STATES: DESCRIBE THE EVENT OR PROBLEM: STENT FOUND TO BE REMOVED FROM THE BALLOON WHEN REMOVING THE STENT CATHETER FROM THE PATIENT. THE STENT WAS FOUND IN THE TUOHY ATTACHED TO THE GUIDE CATHETER. STENT WAS RETRIEVED WITHOUT ANY HARM TO PATIENT. PATIENT MONITORED FOR ADVERSE EFFECTS - NO HARM TO PATIENT. WHOLE STENT WAS ABLE TO BE REMOVED FROM PATIENT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : CARDIAC CATHETERIZATION WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE FAILED (E.G. BROKE, COULD NOT GET IT TO WORK OR STOPPED WORKING). NO ADDITIONAL SIGNIFICANT INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THOUGH REQUESTS WERE MADE, THE DEVICE WAS NOT RECEIVED; IT IS PRESUMED DISCARDED. 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 CROSSING PROFILE AND FOR STENT RETENTION. RISK ASSESSMENT REVIEW INDICATES THAT ADVANCEMENT DIFFICULTY AND STENT DISLODGEMENT ARE CAPTURED AS KNOWN POTENTIAL HAZARDS. THE INVESTIGATION DETERMINED THAT A DEFINITIVE CONCLUSIVE CAUSE IS NOT ABLE TO BE ASSIGNED TO THE REPORTED COMPLAINT. THOUGH UNABLE TO BE CONFIRMED, IN THIS CASE, INABILITY TO CROSS AND SUBSEQUENT STENT DISLODGEMENT MAY POSSIBLY BE ATTRIBUTED INTERACTION WITH CHALLENGING VESSEL MORPHOLOGY, AND / OR A HEMOSTATIC VALVE. 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, A (B)(6)-YEAR OLD FEMALE PATIENT EVALUATED WITH CARDIAC COMPUTERIZED TOMOGRAPHY FOUND 90% CALCIFIED LESION IN THE MODERATELY TORTUOUS PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY PRESENTED FOR PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI). AFTER PRE-DILATATION, AN ATTEMPT WAS MADE TO CROSS THE LESION, VIA FEMORAL ACCESS, WITH A 4.0X24MM COBRA PZF¿ CORONARY STENT SYSTEM BUT THE STENT SYSTEM WAS UNABLE TO CROSS. WHILE RETRACTING THE UNDEPLOYED STENT SYSTEM THROUGH THE TUOHY HEMOSTATIC VALVE, THE STENT DISLODGED INSIDE OF THE VALVE, OUTSIDE OF PATIENT BODY. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH ADDITIONAL INFORMATION WAS REQUESTED, IT WAS NOT PROVIDED BY THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364153 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 170-03-40024 1801234001 00879397000937

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR ROTATING HEMOSTATIC VALVE (RHV): TUOHY BORST.