MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X50CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-56150
Medical Device Problem Codes	Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	06/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a drug leak, requiring catheter replacement.A 135x50cm ekosonic endovascular device was selected to treat a superficial femoral artery thrombus post-impella removal.The catheter was placed around noon, and later that evening, the nurse reported that the leg was completely colorless and had no distal pulses.They were palpable before placing the ekosonic endovascular device.The patient was taken back to the lab, where they found the drug lumen had a pinhole that had been leaking the entire treatment time.The patient never received tpa from the first catheter.It was replaced in the lab with another ekosonic endovascular device.The patient was expected to fully recover.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 135X50CM
• 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: 19700538
• Report Number: 2124215-2024-40362
• Device Sequence Number: 7674144
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K213422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2024

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: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 8035171092
• 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: 06/12/2024
• Initial Report FDA Received Date: 07/09/2024
• Date Device Manufactured: 03/08/2024
• 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 Age: 57 YR
• Patient Sex: Male