MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X50CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-55150
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via attached voluntary medwatch/maude report list # mw5115243 that the ekosonic thrombolysis catheter fractured inside of the patient and the device fragment had to be retrieved by the physician.An ekosonic thrombolysis catheter was selected for use.After the device was placed, the patient bent their leg, causing the ekosonic thrombolysis catheter to fracture inside the vein.The physician had to retrieve the fractured piece of the catheter from the patient.No further adverse consequences to the patient were reported.
Additional Manufacturer Narrative
Device analysis: the ekosonic endovascular device was returned to the complaint investigation site.Only the ultrasonic core (usc) was returned, no infusion catheter (ic).During the visual inspection, it was noticed that the usc was broken at 64cm from the luer barb, just before a significant kink in the usc treatment zone.The reported event of a broken usc was confirmed, and the broken section was confirmed to be removed and returned to the cis.
Event or Problem Description
It was reported via voluntary medwatch/maude report list # mw5115243 that the ekosonic thrombolysis catheter fractured inside of the patient and the device fragment had to be retrieved by the physician.An ekosonic thrombolysis catheter was selected for use.After the device was placed, the patient bent their leg, causing the ekosonic thrombolysis catheter to fracture inside the vein.The physician has to retrieve the fractured piece of the catheter from the patient.No further adverse consequences to the patient were reported.It was further reported that the procedure was completed under fluoroscopy.Once the patient was in the icu, one hour the device was placed, the ekosonic endovascular device stopped working, the physician removed the ultrasonic core (usc) in the icu without the use of fluoroscopy and replaced it with another usc of the same size.The patient's leg was then put into a leg fixation device and remainder of therapy was delivered.Once the patient was brought back for the final fluoroscopy, the physician realized that the first usc had fractured and was pushed out by the second usc.The detached portion of the usc was retrieved, and the patient had a good outcome.There were no further adverse consequences reported for the patient.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X50CM
• 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 MA ; CS
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16643926
• Report Number: 2124215-2023-14765
• Device Sequence Number: 20206426
• Product Code: KRA
• UDI-Device Identifier: 00858593006189
• UDI-Public: 00858593006189
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

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: 11/29/2024
• Device Model Number: 500-55150
• Device Catalogue Number: 500-55150
• Device Lot Number: 8035071696
• 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: 03/08/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• 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