MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC; CATHETER, CONTINUOUS FLUSH

Model Number	6795-007
Medical Device Problem Codes	Material Twisted/Bent (2981); Output Problem (3005)
Health Effect - Clinical Code	Confusion/ Disorientation (2553)
Date of Event	12/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that unplanned sedation occurred.A 135cm x 50cm ekosonic endovascular device was selected for use in a unilateral case to treat a peripheral arterial occlusion (pao) in the right leg.After 4hours and 30 minutes of therapy runtime, the ekos helpline was called due to an e311 no transducer groups enabled alarm on channel b.It was also reported that the patient woke up agitated, confused, and uncooperative.The patient attempted to get out of bed and walk.Therefore, the patient was sedated.In an attempt to troubleshoot the alarm, the unit was reset, and connections were checked.Swapping the device to channel a and a hard reboot were both unsuccessful.Since troubleshooting was unsuccessful, the options were to run the catheter as a standard drip catheter or have the physician come back to exchange the catheter.The patient was in an agitated slumber.No further complications reported.
Event or Problem Description
It was reported that unplanned sedation occurred.A 135cm x 50cm ekosonic endovascular device was selected for use in a unilateral case to treat a peripheral arterial occlusion (pao) in the right leg.After 4hours and 30 minutes of therapy runtime, the ekos helpline was called due to an e311 no transducer groups enabled alarm on channel b.It was also reported that the patient woke up agitated, confused, and uncooperative.The patient attempted to get out of bed and walk.Therefore, the patient was sedated.In an attempt to troubleshoot the alarm, the unit was reset, and connections were checked.Swapping the device to channel a and a hard reboot were both unsuccessful.Since troubleshooting was unsuccessful, the options were to run the catheter as a standard drip catheter or have the physician come back to exchange the catheter.The patient was in an agitated slumber.No further complications reported.It was further reported that the ultrasonic core was kinked upon insertion.The procedure was completed using the catheter as a standard drip catheter.The clot was resolved, and the patient was discharged.
Event or Problem Description
It was reported that unplanned sedation occurred.A 135cm x 50cm ekosonic endovascular device was selected for use in a unilateral case to treat a peripheral arterial occlusion (pao) in the right leg.After 4hours and 30 minutes of therapy runtime, the ekos helpline was called due to an e311 no transducer groups enabled alarm on channel b.It was also reported that the patient woke up agitated, confused, and uncooperative.The patient attempted to get out of bed and walk.Therefore, the patient was sedated.In an attempt to troubleshoot the alarm, the unit was reset, and connections were checked.Swapping the device to channel a and a hard reboot were both unsuccessful.Since troubleshooting was unsuccessful, the options were to run the catheter as a standard drip catheter or have the physician come back to exchange the catheter.The patient was in an agitated slumber.No further complications reported.It was further reported that the ultrasonic core was kinked upon insertion.The procedure was completed using the catheter as a standard drip catheter.The clot was resolved, and the patient was discharged.
Additional Manufacturer Narrative
Correction to h6: evaluation conclusion code.

• Brand Name: EKOSONIC
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21173328
• Report Number: 2124215-2025-01394
• Device Sequence Number: 19984400
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K213422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2025

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 Model Number: 6795-007
• Device Catalogue Number: 6795-007
• Device Lot Number: 8035372152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2024
• Supplement Date Received by Manufacturer: 01/30/2025; 02/25/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/25/2025; 03/24/2025
• Date Device Manufactured: 07/15/2024
• 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: Other
• Patient Age: 75 YR
• Patient Sex: Unknown