BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET? SOLENT? DISTA

    MDR report key: 22994902 · Received September 8, 2025

    Report

    Report Number
    2124215-2025-62493
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    August 12, 2025
    Report Date
    September 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXE
    UDI-DI
    08714729889731
    PMA / PMN Number
    K113363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B - PRO CODE (PRODUCT CODE): DXE, KRA. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, PATIENT INFORMATION, AND INITIAL REPORTER, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PROCEDURE WAS CANCELLED. AN ANGIOJET SOLENT DISTA SOLENT DISTA CATHETER WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BECAME KINKED AND A SALINE ERROR MESSAGE DISPLAYED. ANOTHER ANGIOJET SOLENT DISTA WAS SELECTED. CONSEQUENTLY, THE DEVICE STOPPED WORKING DUE TO AN ERROR MESSAGE. THE ANGIOJET CONSOLE WAS TURNED OFF AND BACK ON BUT THAT DID NOT RESOLVE THE CATHETER ERROR. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2056612 ANGIOJET? SOLENT? DISTA CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION 111303-001 0035069556 08714729889731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown