BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA PZF

    MDR report key: 10522414 · Received September 11, 2020

    Report

    Report Number
    3009306400-2020-00025
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    August 21, 2020
    Report Date
    September 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED (STENT AND DELIVERY SYSTEM), HOWEVER, THE SITE IS UNABLE TO LOCATE THE COMPLAINT 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 ITS PROTECTIVE SHEATH. 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. DEVICE CODING 2017: IT WAS REPORTED THAT THE STENT WAS NOT INSPECTED PRIOR TO USE. IT SHOULD BE NOTED THAT, PER COBRA PZF US COMMERCIAL INSTRUCTIONS FOR USE (IFU) LAS 0147-01, REVISION C, STEP 12.2 PRIOR TO USE STATES: REMOVE PROTECTIVE COVER AND STYLET BY GENTLY GRASPING THE DISTAL END OF THE COVER AND WITHDRAWING DISTALLY. VERIFY THAT THE STENT IS LOCATED BETWEEN THE RADIOPAQUE MARKERS. NOTE: DO NOT USE IF ANY DEFECTS ARE NOTED.

    Description of Event or Problem · 1

    ON (B)(6) 2020, A PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED USING 3.5X30 COBRA PZF NANOCOATED CORONARY STENT SYSTEM. THE PHYSICIAN ADVANCED THE COBRA STENT SYSTEM TO THE TARGET LESION ; WHEN INFLATING THE STENT SYSTEM, THE PHYSICIAN DISCOVERED THAT THE STENT WAS NOT ON THE BALLOON. THE STENT WAS FOUND DAMAGED/DISLODGED, STUCK INSIDE OF ITS PROTECTIVE SHEATH PACKAGING (OCCURRED OUTSIDE OF PATIENT PRIOR TO INSERTION). THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. REPORTEDLY, THE STENT HAD NOT BEEN INSPECTED PRIOR TO INTRODUCING DELIVERY SYSTEM INTO PATIENT. THE TARGET LESION WAS TREATED SUCCESSFULLY WITH ANOTHER COBRA STENT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986980 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 170-03-35030 1912104004 00879397000883

    Patients

    Seq Age Sex Outcome Treatment
    1