BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER

    MDR report key: 15967847 · Received December 13, 2022

    Report

    Report Number
    3009613036-2022-00006
    Event Type
    Malfunction
    Date Received
    December 13, 2022
    Date of Event
    November 5, 2022
    Report Date
    December 13, 2022
    Manufacturer
    MERIL LIFE SCIENCES PRIVATE LIMITED
    Product Code
    LOX
    UDI-DI
    18906029358384
    PMA / PMN Number
    K160961
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF BATCH MANUFACTURING RECORD (BMR) INCLUDING RAW MATERIAL INSPECTION, IN PROCESS & FINISHED PRODUCT INSPECTION, DOES NOT REVEAL ANY DISCREPANCY RELEVANT TO THE BATCH UNDER INVESTIGATION, WHICH CONFIRMS THAT THERE IS NO INDICATION OF A PRODUCT RELATED QUALITY DEFICIENCY ASSOCIATED TO THIS BATCH. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS REPORTED FROM THIS BATCH. CONTROL SAMPLE ANALYSIS RESULTS CONFIRM THAT THERE WAS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY IN THE BATCH UNDER INVESTIGATION. ATTEMPTS WERE MADE TO OBTAINED CONCOMITANT DEVICE AND ADDITIONAL INFORMATION. HOWEVER, ALL REQUESTED INFORMATION AND CONCOMITANT DEVICE WAS NOT RECEIVED. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. BASED ON THE AVAILABLE INFORMATION AND WITHOUT THE CONCOMITANT DEVICE, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. CONSIDERING THE ABOVE AND AS CLINICAL SITUATIONS CANNOT BE DUPLICATED IN OUR ANALYSIS LAB, THE EXACT ROOT CAUSE OF THE DIFFICULTY COULD NOT BE DETERMINED. NEITHER THE BATCH MANUFACTURING RECORD (BMR) REVIEW NOR THE CONTROL SAMPLE ANALYSIS INCLUDING THE COMPLAINT HISTORY REVIEW SUGGESTS THAT THE REPORTED FAILURES COULD BE RELATED TO THE DESIGN OR THE MANUFACTURING PROCESS. NOTE: THIS COMPLAINT IS RECEIVED FROM OUTSIDE THE USA. NO UNITS OF THIS BATCH HAS BEEN DISTRIBUTED IN THE USA. HOWEVER, IT IS BEING REPORTED TO THE USFDA AS THIS PRODUCT IS CLEARED IN THE USA (510(K): K160961).

    Description of Event or Problem · 0

    AS REPORTED, 3.00 X 15 MM MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER WAS USED FOR THE PROCEDURE. IT HAS BEEN STATED THE TRANSITION PROFILE WAS INSUFFICIENT IN THE TRANSITION INTO THE VESSEL AND STENT, THE PROCEDURES WERE FAILURE DUE TO LACK OF SUFFICIENT FLEXIBILITY AND LUBRICITY, THE BALLOON COMPLIANCE WAS LIMITED AND THE RISK OF PROCEDURAL MYOCARDIAL INFARCTION INCREASED DUE TO THE DELAY EXPERIENCED DUE TO THE PROBLEM IN RETRACTION OF THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2298805 MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER LOX MERIL LIFE SCIENCES PRIVATE LIMITED MNC30015 PMNCG16 18906029358384

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Unknown