BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET ZELANTEDVT

    MDR report key: 21574929 · Received March 11, 2025

    Report

    Report Number
    2124215-2025-14952
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    February 12, 2025
    Report Date
    March 31, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXE
    UDI-DI
    08714729904724
    PMA / PMN Number
    K151313
    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): KRA.

    Additional Manufacturer Narrative · 0

    D2B - PRO CODE (PRODUCT CODE): KRA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TIP BREAK OCCURRED. THE ANGIOJET ZELANTEDVT WAS SELECTED FOR USE DURING THE PROCEDURE. THE PHYSICIAN PERFORMED A THROMBECTOMY USING A 12 FR SHEATH, WITH THE SMART CLAW CATHETER ADVANCED OVER A 0.35 GLIDE WIRE AND THE ZELANTE CATHETER ADVANCED OVER A SECOND 0.35 GLIDE WIRE. THE SMARTCLAW THROMBECTOMY WAS PERFORMED ACCORDING TO PROTOCOL. THE ZELANTE CATHETER WAS REMOVED FIRST, FOLLOWED BY THE SMARTCLAW. RESISTANCE WAS ENCOUNTERED DURING THE REMOVAL OF THE ZELANTE CATHETER, AND UPON INSPECTION, IT WAS NOTED THAT THE CATHETER TIP WAS BROKEN, WITH THE DISTAL MARKER AND TIP DETACHED. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE BROKEN FRAGMENT AND PERFORMED AN ANGIOGRAM TO CONFIRM NO RESIDUAL PIECES REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED IN GOOD CONDITION POST-PROCEDURE. IT WAS FURTHER REPORTED THAT THE DEVICE BROKE AT THE DISTAL TIP, SPECIFICALLY AT THE DISTAL MARKER BAND, WHILE INSIDE THE PATIENT. NO ERROR MESSAGE APPEARED DURING THE PROCEDURE, AND THE DEVICE AND PACKAGING WERE INSPECTED BEFORE USE WITHOUT ANY VISIBLE DAMAGE. THE THROMBECTOMY THERAPY WAS ABORTED, AND A CATHETER-DIRECTED THROMBOLYSIS (CDT) PROCEDURE WAS PERFORMED INSTEAD. THE ISSUE AROSE WHILE ATTEMPTING TO REMOVE THE DEVICE INSIDE THE BODY, BUT NO ADDITIONAL DAMAGE TO THE UNIT WAS OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TIP BREAK OCCURRED. THE ANGIOJET ZELANTEDVT WAS SELECTED FOR USE DURING THE PROCEDURE. THE PHYSICIAN PERFORMED A THROMBECTOMY USING A 12 FR SHEATH, WITH THE SMART CLAW CATHETER ADVANCED OVER A 0.35 GLIDE WIRE AND THE ZELANTE CATHETER ADVANCED OVER A SECOND 0.35 GLIDE WIRE. THE SMARTCLAW THROMBECTOMY WAS PERFORMED ACCORDING TO PROTOCOL. THE ZELANTE CATHETER WAS REMOVED FIRST, FOLLOWED BY THE SMARTCLAW. RESISTANCE WAS ENCOUNTERED DURING THE REMOVAL OF THE ZELANTE CATHETER, AND UPON INSPECTION, IT WAS NOTED THAT THE CATHETER TIP WAS BROKEN, WITH THE DISTAL MARKER AND TIP DETACHED. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE BROKEN FRAGMENT AND PERFORMED AN ANGIOGRAM TO CONFIRM NO RESIDUAL PIECES REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED IN GOOD CONDITION POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334177 ANGIOJET ZELANTEDVT CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION 114610-001 0034220429 08714729904724

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female