BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOZEC¿ RX PTCA BALLOON DILATATION CATHETER

    MDR report key: 15453527 · Received September 20, 2022

    Report

    Report Number
    3009613036-2022-00004
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Report Date
    September 20, 2022
    Manufacturer
    MERIL LIFE SCIENCES PRIVATE LIMITED
    Product Code
    LOX
    Adverse Event
    Yes
    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. THE MOZEC SIZE: 1.25 X 15 MM IS NOT APPROVED IN THE US AND NOT COMMERCIALLY AVAILABLE IN THE US MARKET. THE EVENT IS OCCURRED OUTSIDE THE US. HOWEVER, THIS REPORT IS FILED WITH THE USFDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE US (510(K): K131169).

    Description of Event or Problem · 0

    AS REPORTED, 1.25 X 15 MM, MOZEC¿ RX PTCA BALLOON DILATATION CATHETER (BATCH # MOX27, MOX86, PMOD57, PMOD71 AND PMOD72) WERE USED FOR THE PROCEDURE. WHILE THE BALLOON PROCEDURE WAS PERFORMED, THE PROCEDURE TIME INCREASED AS THE PASSAGE PROFILE OF THE BALLOON WAS NOT GOOD. THE SIDE BRANCH OCCLUSION OCCURRED. THE SUCCESS RATE OF THE PROCESS DECREASED AND THE NUMBER OF DEVICES USED INCREASED. *FIVE PRODUCTS WERE INVOLVED IN THIS REPORTED EVENT; THIS REPORT IS APPLICABLE TO BATCH # PMOD71.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2636291 MOZEC¿ RX PTCA BALLOON DILATATION CATHETER RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER LOX MERIL LIFE SCIENCES PRIVATE LIMITED MOZ12515 PMOD71

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male