MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X40CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-55140
Medical Device Problem Codes	Communication or Transmission Problem (2896); Connection Problem (2900); Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 03may2024.The returned device evaluation revealed that the device had a separated ultrasonic core, and the drug and coolant luers were cracked and leaking.This ekosonic endovascular device, 106x40cm was selected for use in a unilateral deep vein thrombosis procedure.Alarms e006, e302, and e311 were observed during treatment which were unable to be resolved despite troubleshooting attempts.Therefore, the catheter was used as a standard infusion catheter to complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this ekos device was visually inspected for abnormalities, and it was found that the ultrasonic core (usc) was separated at approximately 73.5 cm from the luer barb.Additionally, the drug and coolant luers were cracked.Functional testing of the complaint device was not possible because the usc was broken and would not function.The coolant and drug ports leaked liquid from where the cracking was present.The reported event of multiple error messages was not confirmed.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X40CM
• 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: 19305443
• Report Number: 2124215-2024-28983
• Device Sequence Number: 7321234
• Product Code: KRA
• UDI-Device Identifier: 00858593006172
• UDI-Public: 00858593006172
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/21/2025
• Device Model Number: 500-55140
• Device Catalogue Number: 500-55140
• Device Lot Number: 8035335491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown