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

Model Number	500-56150
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on analysis completed on 13sep2024.The returned device evaluation revealed the infusion catheter tubing was severed.It was reported that the device leaked liquid during flushing.During the initial procedure in the catheterization laboratory, this 135x50cm ekosonic endovascular device was successfully set up, then leaking was observed during flushing.It was unknown if the liquid was drug or coolant.The procedure was completed with another ekos device and there were no patient complications.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, microscopic visual inspection of this ekosonic endovascular device infusion catheter (ic) showed a crack in the manifold luer, where the ultrasound core (usc) was inserted into the ic.The device was tested for leaking, and it was observed that the device leaked liquid from the manifold luer, where the crack was observed.The reported clinical observation was confirmed.Additionally, it was observed that the ic tubing was severed at approximately 40cm from the strain relief.The detached portion of the tubing was returned.It was unable to be determined what caused or contributed to the device separation, or if the separation happened during, or post procedure.

• 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: 20283028
• Report Number: 2124215-2024-57763
• Device Sequence Number: 7987609
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2024

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 Expiration Date: 05/18/2026
• Device Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 8035638831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown