MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X30CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-56130
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that entrapment on the guidewire occurred.An ekosonic endovascular device, 135x30cm was selected for use in the thrombectomy procedure in the superficial femoral artery (sfa) and the profunda artery.There was difficulty advancing the infusion catheter (ic) into the profunda artery, as well as difficulty advancing the ultrasonic core (usc) into the ic.The partially inserted usc was removed, and a non-bsc guidewire was inserted to better seat the ic deeper within the artery.After advancing the ic further into the artery to the target lesion, the guidewire was unable to be removed from the ic.Both the guidewire and ic were removed from the patient together.The catheter was exchanged for another type of catheter in order to complete the procedure.There were no reported adverse consequences to the patient.
Additional Manufacturer Narrative
Device media analysis: microscopic visual inspection of the device did not show any significant kinking or stretching of the ic, and the usc was not significantly damaged, either.Functional testing revealed resistance when a 0.035 in guide wire was advanced through the strain relief of the ic.The guidewire was removed so the usc could be inserted through the ic lumen.Resistance was met when the usc was inserted into the lumen.The manifold was disassembled, and the strain relief rubber was removed.Significant kinking was observed under the strain relief rubber, which is consistent with damage caused by difficulty advancing the catheter.
Event or Problem Description
It was reported that entrapment on the guidewire occurred.An ekosonic endovascular device, 135x30cm was selected for use in the thrombectomy procedure in the superficial femoral artery (sfa) and the profunda artery.There was difficulty advancing the infusion catheter (ic) into the profunda artery, as well as difficulty advancing the ultrasonic core (usc) into the ic.The partially inserted usc was removed, and a non-bsc guidewire was inserted to better seat the ic deeper within the artery.After advancing the ic further into the artery to the target lesion, the guidewire was unable to be removed from the ic.Both the guidewire and ic were removed from the patient together.The catheter was exchanged for another type of catheter in order to complete the procedure.There were no reported adverse consequences to the patient.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 135X30CM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16273478
• Report Number: 2124215-2023-03169
• Device Sequence Number: 5991463
• Product Code: KRA
• UDI-Device Identifier: 00858593006295
• UDI-Public: 00858593006295
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K182324
• 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): 03/06/2023

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: 08/05/2024
• Device Model Number: 500-56130
• Device Catalogue Number: 500-56130
• Device Lot Number: 8035045624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown