BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EKOSONIC ENDOVASCULAR DEVICE, 106X18CM

    MDR report key: 14268802 · Received May 3, 2022

    Report

    Report Number
    2134265-2022-04889
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    April 8, 2022
    Report Date
    June 1, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    UDI-DI
    00858593006141
    PMA / PMN Number
    K183361
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # FILED ON 3500A FORM: K182324.

    Additional Manufacturer Narrative · 0

    G4. PMA/510(K) # FIELD ON 3500A FORM: K182324 E4. INIT RPTR ALSO SENT REP TO FDA UPDATED TO YES B5. UPDATED EVENT DESCRIPTION OR PROBLEM DEVICE EVALUATION THE RETURNED DEVICE CONSISTED OF THE INFUSION CATHETER (IC) AND THE ULTRASONIC CORE (USC) CUT OFF AT THE CABLE. THE DEVICE WAS INSPECTED FOR DAMAGE OR IRREGULARITIES. THERE WAS BLOOD THROUGHOUT THE DEVICE. THE IC HAD A KINK AT ROUGHLY 88.7CM AS WELL AS SOME WAVY WIRES. THE USC HAD THE OBVIOUS DAMAGE OF A SEPARATION. THE SEPARATION WAS 96.8CM FROM THE LUER LOCK. THE SEPARATED PORTION MEASURED 17.8CM. THE TOTAL DEVICE LENGTH RETURNED WAS ROUGHLY 114.6CM; THIS IS WITHIN THE DEVICE SPECIFICATION WHICH SUPPORTS THAT THE ENTIRE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE REASON FOR THE USC FRACTURE WAS UNABLE TO BE DETERMINED. IT IS UNKNOWN WHEN THE USC BECAME COMPLETELY SEPARATED OR WHAT CAUSED IT TO FALL OUT OF THE IC AND BECOME STUCK IN THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER FRACTURE OCCURRED. AN EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR THE TREATMENT OF DEEP VEIN THROMBOSIS (DVT) IN THE RIGHT LEG. DURING THERAPY, AN ALARM WAS RECEIVED ON THE CONTROL UNIT INDICATING POOR CONNECTION BETWEEN THE INFUSION CATHETER AND THE ULTRASONIC CORE. DURING TROUBLESHOOTING, ANOTHER ALARM INDICATING THAT THE RADIO-FREQUENCY BOARD IS UNABLE TO COMMUNICATE WITH THE CONNECTOR INTERFACE CABLE WAS RECEIVED. THE ALARMS WERE UNRESOLVED THROUGH TROUBLESHOOTING, SO THERAPY WAS CONTINUED USING THE CATHETER AS A STANDARD INFUSION CATHETER. THE FOLLOWING DAY, DURING A RECHECK OF THE DVT, THE ULTRASOUND WIRE WAS FOUND TO BE BROKEN OFF THE TRANSITION OF THE TRANSDUCERS. THE FRACTURED ULTRASOUND WIRE WAS SNARED OUT OF THE POPLITEAL VEIN. THE TREATMENT WAS COMPLETED WITHOUT ANY INTERRUPTION OF TPA DELIVERY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER FRACTURE OCCURRED. AN EKOSONIC VASCULAR DEVICE WAS SELECTED FOR THE TREATMENT OF DEEP VEIN THROMBOSIS (DVT) IN THE RIGHT LEG. DURING THERAPY, AN ALARM WAS RECEIVED ON THE CONTROL UNIT INDICATING POOR CONNECTION BETWEEN THE INFUSION CATHETER AND THE ULTRASONIC CORE. DURING TROUBLESHOOTING, ANOTHER ALARM INDICATING THAT THE RF BOARD IS UNABLE TO COMMUNICATE WITH THE CONNECTOR INTERFACE CABLE WAS RECEIVED. THE ALARMS WERE UNRESOLVED THROUGH TROUBLESHOOTING, SO THERAPY WAS CONTINUED USING THE CATHETER AS A STANDARD INFUSION CATHETER. THE FOLLOWING DAY, DURING A RECHECK OF THE DVT, THE ULTRASOUND WIRE WAS FOUND TO BE BROKEN OFF THE TRANSITION OF THE TRANSDUCERS. THE FRACTURED ULTRASOUND WIRE WAS SNARED OUT OF THE POPLITEAL VEIN. THE TREATMENT WAS COMPLETED WITHOUT ANY INTERRUPTION OF TISSUE PLASMINOGEN ACTIVATOR (TPA) DELIVERY. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS CARRIED OUT THROUGH PEDAL ACCESS USING THE DORSALIS PEDIS VEIN AND ANTERIOR TIBIAL VEIN, WHICH CONFIRMED THE FINDINGS OF THE DVT IN THE RIGHT POPLITEAL VEIN EXTENDING INTO THE DISTAL RIGHT SUPERFICIAL FEMORAL VEIN. SEVERAL ROUNDS OF ASPIRATION THROMBECTOMY AND BALLOON VENOPLASTY WERE CARRIED OUT WITH SOME IMPROVEMENT IN THE FLOW. THE VEIN RECOILED AND THERE WAS STILL COMPLETE OCCLUSION. THEREFORE, PHARMACOMECHANICAL THROMBOLYSIS CATHETER WAS PLACED OVERNIGHT TO INFUSE 0.5MG OF TPA PER HOUR ALONG WITH HEPARIN AND AN EKOS CATHETER WAS PLACED. THE CATHETER WAS REMOVED THE NEXT DAY AND FOLLOW UP VENOGRAPHY INDICATED COMPLETE RESOLUTION OF THE CLOT AND INDICATED A BROKEN PIECE OF THE DISTAL TIP OF THE ULTRASOUND CORE OF THE EKOS CATHETER. THE BROKEN TIP OF THE USC WAS RETRIEVED USING A SNARE. ON THE DAY OF DISCHARGE, VENOGRAPHY SHOWED THAT THE PATIENT HAD A COMPLETE NORMAL VENOUS RETURN WITH RESOLUTION OF THE THROMBUS IN THE RIGHT POPLITEAL VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2073562 EKOSONIC ENDOVASCULAR DEVICE, 106X18CM CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION 500-55118 8035083406 00858593006141

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention