MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X40CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-56140
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a fracture occurred requiring additional intervention.An ekosonic endovascular device, 135x40cm was selected for use in the leg.When the ultrasonic core (usc) was advancing within the infusion catheter (ic), resistance was noted.The physician took an x-ray and saw that the usc had fractured entirely within the microcatheter inside of the patient.The physician was able to retrieve the broken portion of the usc using a snare.The entire ekos device was removed and replaced, and the procedure was completed.There were no patient complications, and the patient is doing well.
Additional Manufacturer Narrative
Device analysis: the ekos device was returned to the complaint investigation site (cis).Only the usc was returned.Upon inspection, it was observed that the cord was cut, and the usc was broken at approximately 100.5cm from the luer barb.The reported event of a break in the usc was confirmed.
Event or Problem Description
It was reported that a fracture occurred requiring additional intervention.An ekosonic endovascular device, 135x40cm was selected for use in the leg.When the ultrasonic core (usc) was advancing within the infusion catheter (ic), resistance was noted.The physician took an x-ray and saw that the usc had fractured entirely within the microcatheter inside of the patient.The physician was able to retrieve the broken portion of the usc using a snare.The entire ekos device was removed and replaced, and the procedure was completed.There were no patient complications, and the patient is doing well.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 135X40CM
• 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: 17031887
• Report Number: 2124215-2023-26309
• Device Sequence Number: 7012400
• Product Code: KRA
• UDI-Device Identifier: 00858593006301
• UDI-Public: 00858593006301
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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: 01/15/2026
• Device Model Number: 500-56140
• Device Catalogue Number: 500-56140
• Device Lot Number: 8035408741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• 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