BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS

    MDR report key: 20956392 · Received December 17, 2024

    Report

    Report Number
    3005099803-2024-06459
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    November 1, 2024
    Report Date
    December 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRODUCT CODE: PCU, QXH; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET/510(K): DEN230019, K150692, K153088, K181905, K220112, K233318; REPORTED HERE AS THE PREMARKET/510(K)# EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A150103 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE PREMATURELY DEPLOYED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE PANCREAS TO TREAT A PANCREATIC FLUID COLLECTION DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, FIRST FLANGE OF THE STENT PREMATURELY DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND ANOTHER AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1456631 AXIOS UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00553650 0033559656

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown