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

Model Number	500-56140
Medical Device Problem Codes	Break (1069); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a break occurred requiring additional intervention.A 135x40cm ekosonic endovascular device was selected for use.During the procedure, the console kept giving an alarm.The ultrasonic core was left in.During removal of the ultrasonic core, some of the distal portion broke off.When the.035 wire was pushed through the wire port, the remaining portion of the unltrasonic core wire was pushed out of the distal end.Attempts made to snare the device out of the patient were unsuccessful.A popliteal cut down was performed to retrieve the foreign body.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the ekosonic endovascular device was returned for analysis.The ultrasonic core (usc) was broken approximately 100cm from the luer barb, at the start of the treatment zone.Additionally, the treatment zone was severely kinked.The infusion catheter (ic) was cut at approximately 44cm from the strain relief.This was likely performed after the procedure.The usc was unable to be functionally tested because it was broken.The reported error message was unable to be confirmed; however, it is likely that the error messages were caused by the kinked and broken usc.

• 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: 18006826
• Report Number: 2124215-2023-59331
• Device Sequence Number: 20467737
• Product Code: KRA
• UDI-Device Identifier: 00858593006301
• UDI-Public: 00858593006301
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 10/25/2023

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: 09/12/2025
• Device Model Number: 500-56140
• Device Catalogue Number: 500-56140
• Device Lot Number: 8035237501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2022
• 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