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

Model Number	500-56150
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Advance (2524); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ultrasonic core broke.A 135x50cm ekosonic endovascular device was selected for use in a thrombolysis procedure to treat an occluded superficial femoral artery (sfa).During preparation, the catheter was vigorously flushed, and the ultrasonic core was inserted into the catheter, but it became stuck.Advancing the ultrasonic core wore through the catheter; it became kinked.It was very hard to push, and then very hard to pull out.Upon pulling the ultrasonic core back, it broke in two.The ultrasonic core was sticking out of the catheter and was grasped with a hemostat and pulled completely and fully out of the catheter.The catheter was fully intact and was successfully removed from patient.The procedure was completed with a good outcome using a non-boston scientific infusion catheter.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: the ekosonic endovascular device was returned for analysis.Visual inspection confirmed that there were kinks in the infusion catheter approximately 28cm and 113cm from the strain relief.It was also observed that the ultrasonic core was broken and detached approximately 90cm from the luer barb.The reported events were confirmed.

• 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: 20360063
• Report Number: 2124215-2024-61906
• Device Sequence Number: 8126756
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/03/2024

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 Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 8035309232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male