MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X18CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-55118
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the hub leaked requiring additional intervention.Two ekosonic endovascular device, 106x18cm were selected for use.While in the cardiac catheterization lab (ccl), the first catheter was placed within 15 minutes.The second catheter placement took approximately an hour to seat it in the left lobe of the lung.The patient was transferred to the intensive care unit (icu) where the pumps were connected.Upon inspection, it was noted that the left catheter was leaking at the drug port.Upon further inspection, the plastic was brittle and broke off where it connected to the stop cock.The patient was brought back to the ccl and the catheter was swapped successfully.The pumps were hooked up and the patient was transferred back to the icu.After 20 minutes the new left catheter also started to leak.The leak was durabond and taped and appeared to be holding.The patient did not receive the adequate amount of lytic and was brought back for an additional angio and right heart catheterization.There were no patient complications.
Additional Manufacturer Narrative
A4: weight: nearly 500 pounds.Device evaluated by mfr: the ekosonic endovascular device was returned for analysis.Microscopic visual inspection of the infusion catheter showed a crack in the coolant luer and the drug luer was shattered.The device was tested for leaking, and it was noticed that the device did not leak from the coolant luer, despite the cracking.The drug luer was unable to be attached to a syringe, as the luer connection was completely broken off, but would have leaked if it were attached.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X18CM
• 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: 19656378
• Report Number: 2124215-2024-40641
• Device Sequence Number: 6822805
• Product Code: KRA
• UDI-Device Identifier: 00858593006141
• UDI-Public: 00858593006141
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2024

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 Expiration Date: 08/15/2026
• Device Model Number: 500-55118
• Device Catalogue Number: 500-55118
• Device Lot Number: 8035745081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• 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: Female