MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X12CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-56112
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device was found to be leaking, requiring intervention.This ekosonic endovascular device, 135x12cm was selected for use in a bilateral pulmonary embolism procedure.After the catheters were placed, approximately one hour into treatment, the luers were noted to be leaking.The patient was brought to the catheterization laboratory to replace the catheters.There were no patient complications.
Event or Problem Description
It was reported that the device was found to be leaking, requiring intervention.This ekosonic endovascular device, 135x12cm was selected for use in a bilateral pulmonary embolism procedure.After the catheters were placed, approximately one hour into treatment, the luers were noted to be leaking.The patient was brought to the catheterization laboratory to replace the catheters.There were no patient complications.It was further reported that when the leaking was observed, an attempt was made to tighten the luers; however, it was then observed that there were holes at the luers.One catheter leaked from the drug and coolant luer, and one leaked from the drug luer.
Event or Problem Description
It was reported that the device was found to be leaking, requiring intervention.This ekosonic endovascular device, 135x12cm was selected for use in a bilateral pulmonary embolism procedure.After the catheters were placed, approximately one hour into treatment, the luers were noted to be leaking.The patient was brought to the catheterization laboratory to replace the catheters.There were no patient complications.It was further reported that when the leaking was observed, an attempt was made to tighten the luers; however, it was then observed that there were holes at the luers.One catheter leaked from the drug and coolant luer, and one leaked from the drug luer.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
• 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: 19372905
• Report Number: 2124215-2024-31178
• Device Sequence Number: 12682164
• Product Code: KRA
• UDI-Device Identifier: 00858593006264
• UDI-Public: 00858593006264
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 06/20/2024

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: 03/08/2026
• Device Model Number: 500-56112
• Device Catalogue Number: 500-56112
• Device Lot Number: 8035509711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 05/22/2024; 06/17/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/11/2024; 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EKOS CATHETER; EKOS CATHETER; EKOS CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown