MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X50CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-56150
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number - reported as - 8035053232.
Event or Problem Description
It was reported the ultrasonic core (us wire) fractured.A 135cm 50cm ekosonic kit was used during a bilateral deep vein thrombosis (dvt) therapy procedure.Ten hours into treatment, an alarm occurred, and was unable to be resolved through troubleshooting so ultrasound was discontinued and treatment was continued by using the ekos catheter as an infusion catheter.Later on, the patient was sent for recheck and it was discovered that the us wire broke and had migrated into the patient's vasculature.The fractured portion was able to be successfully snared out of the patients left iliac vein and all ekos components were removed.Blood flow was restored to the patients left leg despite the problem with the us wire.The physician was able to use a manual suction device to remove the residual clot residue left over and then performed angioplasty and finally placed a wallstent.No further patient complications occurred and the physician was happy with the overall result.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned with both the infusion catheter (ic) and ultrasonic core (usc) with the cords cut.The device was inspected for any damage or irregularities.The usc device showed the obvious damage of a complete separation roughly 90cm from the luer barb just before the first node.The piece that had separated was roughly 51.6cm and included the entire treatment zone.Based on the damage and size of the returned pieces it is believed that the entire separated section of the usc was successfully removed from the patient.Roughly 5cm into the separated portion of the usc a severe kink as noticed.It appears likely this happened during the extraction of this portion.There was no other obvious damage that could have contributed to the separation of the device.There was no obvious damage with the ic.The event log shows therapy was started on (b)(6) 2022.The ultrasonic core (usc) sn:(b)(6), infusion catheter (ic) sn:(b)(6) connected.Therapy ran for 1 hour and 36 minutes before an all msd groups disabled alert occurred.The alert resolved and occurred again at approximately 9 hours 41 minutes into therapy.The alert persisted before the user pressed the stop button.This appeared to have been a problem with the catheter itself and the control unit functioned as intended without issue.
Event or Problem Description
It was reported the ultrasonic core (us wire) fractured.A 135cm 50cm ekosonic kit was used during a bilateral deep vein thrombosis (dvt) therapy procedure.Ten hours into treatment, an alarm occurred, and was unable to be resolved through troubleshooting so ultrasound was discontinued and treatment was continued by using the ekos catheter as an infusion catheter.Later on, the patient was sent for recheck and it was discovered that the us wire broke and had migrated into the patient's vasculature.The fractured portion was able to be successfully snared out of the patients left iliac vein and all ekos components were removed.Blood flow was restored to the patients left leg despite the problem with the us wire.The physician was able to use a manual suction device to remove the residual clot residue left over and then performed angioplasty and finally placed a wallstent.No further patient complications occurred and the physician was happy with the overall result.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 135X50CM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): COYOL BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera propark; coyol alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13733224
• Report Number: 2134265-2022-02220
• Device Sequence Number: 17169906
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K182324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2022

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: 09/05/2024
• Device Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 8035054296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown