MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X18CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-55118
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
Pma/510(k) # filed on 3500a form: k182324.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X18CM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14268802
• Report Number: 2134265-2022-04889
• Device Sequence Number: 14929360
• Product Code: KRA
• UDI-Device Identifier: 00858593006141
• UDI-Public: 00858593006141
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K183361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2025
• Device Model Number: 500-55118
• Device Catalogue Number: 500-55118
• Device Lot Number: 8035083406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown