MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X30CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-55130
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: estimated, as this date was not provided.
Event or Problem Description
It was reported this device was leaking and the patient developed pneumothorax.This 106x30cm ekosonic endovascular device was selected for use in a pulmonary embolism procedure.The catheter was placed, and the patient was taken to the intensive care unit for treatment overnight.Leaking from the drug port was later observed.Per physicians orders, the coolant and drug were infused together through the coolant port.Additionally, it was noted that the patient developed pneumothorax.Additional information has been requested but is not available at this time.If additional information is received, this report will be updated.
Additional Manufacturer Narrative
B3: date of event: estimated, as this date was not provided.Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, microscopic visual inspection of this ekosonic endovascular device revealed that the drug luer displayed cracking.The device was tested for leaks, and it was noticed that the device leaked from the drug luer where the cracks were present.The reported event of a leak was confirmed.
Event or Problem Description
It was reported this device was leaking and the patient developed pneumothorax.This 106x30cm ekosonic endovascular device was selected for use in a pulmonary embolism procedure.The catheter was placed, and the patient was taken to the intensive care unit for treatment overnight.Leaking from the drug port was later observed.Per physicians orders, the coolant and drug were infused together through the coolant port.Additionally, it was noted that the patient developed pneumothorax.Additional information has been requested but is not available.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X30CM
• 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: 18979077
• Report Number: 2124215-2024-18164
• Device Sequence Number: 6665932
• Product Code: KRA
• UDI-Device Identifier: 00858593006165
• UDI-Public: 00858593006165
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 04/02/2024

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: 05/13/2025
• Device Model Number: 500-55130
• Device Catalogue Number: 500-55130
• Device Lot Number: 8035100782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown