BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET® SOLENT¿ OMNI

    MDR report key: 6278693 · Received January 26, 2017

    Report

    Report Number
    2134265-2017-00087
    Event Type
    Malfunction
    Date Received
    January 26, 2017
    Date of Event
    December 27, 2016
    Report Date
    December 28, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K111182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A SOLENT OMNI THROMBECTOMY SYSTEM WITH NO OTHER DEVICES. THE PUMP, SHAFT, AND TIP WERE MICROSCOPICALLY EXAMINED AND A KINK WAS OBSERVED 7 ½ CM FROM THE TIP. FUNCTIONAL TESTING WAS PERFORMED BY PLACING THE DEVICE IN THE CONSOLE. FUNCTIONAL TESTING SHOWED A LEAK AT THE MALE CONNECTOR WITH FEMALE LUER. FLUID LEAKING FROM THE CONNECTOR IS IN INDICATION THAT THE OUTLET ADAPTER SEAL FAILED. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED DIFFICULTY IS A DESIGN CONSTRAINT OF THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A LOSS OF ASPIRATION OCCURRED DURING THE PROCEDURE. AN ANGIOJET® SOLENT¿ OMNI THROMBECTOMY CATHETER WAS SELECTED FOR USE IN THE PROXIMAL REGION OF THE FEMORAL ARTERIAL SYSTEM. THE CATHETER WAS SUCCESSFULLY PRIMED AND WAS ABLE TO RUN IN THROMBECTOMY MODE FOR 15-20 SECONDS BEFORE RECEIVING AN ERROR MESSAGE "CHECK LINE/RESET". AN ATTEMPT TO "RESET".THE CATHETER/CONSOLE WAS MADE BUT THE PHYSICIAN ENDED UP REMOVING THE CATHETER FROM THE CONSOLE AND REINSERTING THE PUMP ASSEMBLY INTO DRAWER. AT WHICH TIME IT WAS NOTICED TO BE LEAKING SALINE FROM THE PUMP. THE PHYSICIAN DECIDED TO STOP THE USE OF THROMBECTOMY AS ANOTHER CATHETER WAS NOT AVAILABLE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS NOTED THE CASE WAS RESOLVED WITH OVERNIGHT THERAPY OF A CATHETER DIRECTED LYTIC (CDL). THE NEXT DAY, ONCE THE THROMBUS WAS RESOLVED VIA OVERNIGHT CDL, ATHRECTOMY AND DRUG COATED BALLOON ANGIOPLASTY WERE PERFORMED ON AN UNDERLYING LESION IN THE SAME ANATOMICAL REGION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63384 ANGIOJET® SOLENT¿ OMNI CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 109681-001 19942368

    Patients

    Seq Age Sex Outcome Treatment
    1