MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X12CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-55112
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 01 dec 2023.The returned device evaluation revealed there was a fracture.It was reported that this catheter would not cross/track.This 106x12cm ekosonic endovascular device was selected for use in a pulmonary embolism procedure.During the procedure, the catheter would not cross or track.The procedure was completed with a new catheter and there were no patient complications.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this ekosonic endovascular device was visually inspected.It was found that the ultrasonic core (usc) was fractured in two pieces at approximately 102cm from the luer barb.The detached piece of the usc was not returned.The infusion catheter (ic) had small pinches at 61, 84, and 96cm from the strain relief.A ring gauge of was passed over the ic to confirm the outer diameter and had difficulty passing over multiple spots that coincided with the pinches noticed between 60-100cm from the ic strain relief.A guidewire was then inserted into the bend jig, and the ic was advanced over the guidewire.The ic met significant resistance when inserted into the tip of the ic, approximately 96cm from the strain relief, and was unable to be advanced.The usc was inserted into the distal end of the ic and met resistance approximately 66cm from the strain relief of the ic.It was not possible to advance the usc or the guidewire through the section that was 66-94cm from the strain relief.Dye was injected into the central lumen to help visualize changes to the diameter of the central lumen.It was noticed that the pinches at 63cm and 96cm from the strain relief were significant enough to prevent the advancement of the ic over the guidewire.The reported event of difficulty advancing the catheter over the guidewire was confirmed.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X12CM
• 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: 18287994
• Report Number: 2124215-2023-69694
• Device Sequence Number: 20500121
• Product Code: KRA
• UDI-Device Identifier: 00858593006134
• UDI-Public: 00858593006134
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/07/2023

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: 04/27/2026
• Device Model Number: 500-55112
• Device Catalogue Number: 500-55112
• Device Lot Number: 8035603561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown