BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET SOLENT PROXI

    MDR report key: 20675595 · Received November 13, 2024

    Report

    Report Number
    2124215-2024-70625
    Event Type
    Malfunction
    Date Received
    November 13, 2024
    Date of Event
    July 16, 2024
    Report Date
    December 2, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXE
    UDI-DI
    08714729889595
    PMA / PMN Number
    K101406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE- DXE, KRA.

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE- DXE, KRA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LOSS OF ASPIRATION OCCURRED. AN ANGIOJET SOLENT PROXI WAS SELECTED FOR TREATMENT.DURING THE PROCEDURE, THE DEVICE WAS USED BUT FAILED TO PROVIDE SUCTION. THE MACHINE WAS RESTARTED, AND BOTH CATHETERS WERE RE-PRIMED, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THEE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LOSS OF ASPIRATION OCCURRED. AN ANGIOJET SOLENT PROXI WAS SELECTED FOR TREATMENT.DURING THE PROCEDURE, THE DEVICE WAS USED BUT FAILED TO PROVIDE SUCTION. THE MACHINE WAS RESTARTED, AND BOTH CATHETERS WERE RE-PRIMED, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE ANGIOJET FAILED TO READ THE CATHETERS THAT WERE BEING INSERTED. THE DEVICE DID NOT CONTINUE TO PUMP OR INFUSE SALINE AFTER ASPIRATION WAS LOST. THE SYSTEM FAILED TO READ CATHETERS AND WOULD NOT ADVANCE PAST THAT PHASE AND WAS IN THROMBECTOMY MODE BY DEFAULT. NO VISIBLE DEFECTS, SUCH AS LEAKS, BREAKS, OR KINKS, WERE OBSERVED DURING THE INCIDENT. THERE WERE NO ISSUES NOTED WITH ANY SPECIFIC PART OF THE DEVICE, SUCH AS THE PUMP, MID-SHAFT, TUBING, OR LUER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2314527 ANGIOJET SOLENT PROXI CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION 109676-001 0034484603 08714729889595

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown