BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIFLEX RX PUSHER

    MDR report key: 16152963 · Received January 12, 2023

    Report

    Report Number
    3005099803-2022-08084
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    December 21, 2022
    Report Date
    January 18, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: MEDICAL DEVICE PROBLEM CODE A020503 CAPTURES THE REPORTABLE EVENT OF PACKAGING SEAL COMPROMISED. BLOCK H11: BLOCK H6 DEVICE CODE HAS BEEN CORRECTED FROM UNSEALED DEVICE PACKAGING (A020503) TO TEAR, RIP OR HOLE IN DEVICE PACKAGING (A020504) BASED ON THE PHOTO PROVIDED OF THE COMPLAINT DEVICE THAT SHOWED MINIMAL PACKAGING DAMAGED AND THE DEVICE SEAL WAS NOT COMPROMISED. BOSTON SCIENTIFIC NO LONGER CONSIDERS THIS TO BE A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ON DECEMBER 21, 2022, THE INNER BOX OF AN ADVANIX PANCREATIC STENT WAS FOUND DAMAGED. THERE WAS NO PROCEDURE AND PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ON (B)(6) 2022, THE INNER BOX OF AN ADVANIX PANCREATIC STENT WAS FOUND DAMAGED. THERE WAS NO PROCEDURE AND PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065795 NAVIFLEX RX PUSHER CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION UNK-P-ADVANIX_PANCREATIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown