BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA PZF

    MDR report key: 10031050 · Received May 6, 2020

    Report

    Report Number
    3009306400-2020-00018
    Event Type
    Malfunction
    Date Received
    May 6, 2020
    Date of Event
    April 8, 2020
    Report Date
    July 21, 2020
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397000678
    PMA / PMN Number
    P160014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED 06 JUL 2020 IN THE FOLLOWING CONDITION: BALLOON WAS LOOSELY FOLDED, THAT INFLATION / DEPLOYMENT ATTEMPT WAS MADE; STENT WAS NOT RECEIVED WITH THE DELIVERY SYSTEM. INABILITY TO INFLATE THE DELIVERY SYSTEM WAS ABLE TO BE REPLICATED AND WAS CONFIRMED TO BE ATTRIBUTED TO A HYPOTUBE KINK DISCOVERED NEAR THE PROXIMAL STRAIN RELIEF. INABILITY TO DEPLOY / INFLATE STENT WAS CONFIRMED TO BE ATTRIBUTED TO A HYPOTUBE KINK NEAR THE PROXIMAL STRAIN RELIEF; THIS LIKELY RESULTED IN LOOSENING OF THE STENT DURING INFLATION AND SUBSEQUENT DISLODGEMENT AFTER USE, WHICH IS EVIDENCED BY THE LOOSE / PARTIALLY EXPANDED BALLOON RECEIVED WITHOUT ITS STENT. CAUSE OF THE KINK (LIKELY RESULTING IN DEPLOYMENT DIFFICULTY AND DISLODGEMENT (AFTER USE)) WAS UNABLE TO BE CONFIRMED, BUT MAY BE ATTRIBUTED TO, BUT NOT LIMITED TO, THE FOLLOWING: STENT SYSTEM MAY HAVE BECOME DAMAGED DURING ROUGH REMOVAL FROM HOOP, RESULTING IN COMPROMISED INTEGRITY OF INFLATION LUMEN; CATHETER KINK MAY HAVE OCCURRED DURING ADVANCEMENT / TORQUE OF THE DEVICE. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT. THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS, INCLUDING FOR STENT RETENTION. RISK ASSESSMENT REVIEW INDICATES THAT INABILITY TO DEPLOY STENT AND DISLODGEMENT ARE CAPTURED AS KNOWN POTENTIAL HAZARDS. 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 · 0

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A 2.5X15MM COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM WAS ADVANCED TO A LESION IN AN UNSPECIFIED VESSEL. AN ATTEMPT WAS MADE TO DEPLOY THE STENT, BUT THE STENT DID NOT DEPLOY. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS RECEIVED WITH ITS BALLOON PARTIALLY INFLATED AND WITHOUT ITS STENT. ADDITIONAL INFORMATION WAS REQUESTED FROM THE SITE; THE SITE INDICATED THAT WHILE THEY WERE UNAWARE OF ANY STENT DISLODGEMENT, THEY HAD CONFIRMED UNDER FLUOROSCOPY THAT THERE WAS NO STENT DISLODGED IN THE PATIENT AND THEY DO NOT RECOLLECT ANY OCCURRENCE OF INTENTIONAL MANIPULATION OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS ESTIMATED. THE DEVICE WAS REQUESTED, BUT HAS NOT YET BEEN RECEIVED. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCES. THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS. RISK ASSESSMENT REVIEW INDICATES THAT INABILITY TO DEPLOY STENT IS CAPTURED AS A KNOWN POTENTIAL HAZARD. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A 2.5X15MM COBRA PZF NANOCOATED CORONARY STENT SYSTEM WAS ADVANCED TO A LESION IN AN UNSPECIFIED VESSEL. AN ATTEMPT WAS MADE TO DEPLOY THE STENT, BUT THE STENT DID NOT DEPLOY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493926 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 170-03-25015 1708294002 00879397000678

    Patients

    Seq Age Sex Outcome Treatment
    1