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

Model Number	500-56150
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 31 mar 2023.An ekos endovascular device, 135x50cm was selected for use in the angioplasty procedure to treat the patient's deep vein thrombosis.The catheter was placed in the catheterization lab, and the patient was transferred to the icu to complete treatment.Shortly after the patient arrived in the icu, it was noted that the patient's bedding was wet.The physician was notified.It was observed that clear fluid was dripping from somewhere around the white portion of the catheter.It was undetermined whether the fluid was lytic or coolant.The physician exchanged the ekos endovascular device while the patient was still in the icu.The issue was resolved, and the patient received the intended amount of lytic from the second device.There were no reported adverse consequences to the patient.However, device analysis revealed the device was leaking from the drug lumen.
Additional Manufacturer Narrative
Device analysis: the ekosonic endovascular device was returned to the complaint investigation site.Microscopic visual inspection of usc showed slight pinching of the wire at 5cm, and 45cm from the luer barb.Inspection of the ic showed wavy wires.During leak testing, it was observed that the device leaked from the drug lumen out of the tip of the strain relief.The hub was disassembled, and the strain relief was removed to pinpoint the leak.The leak appeared to be coming from the hub section just before the strain relief.It appeared that the tubing was severed at this point.The reported event of a leak from the catheter hub was 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16811864
• Report Number: 2124215-2023-19915
• Device Sequence Number: 20579846
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2023

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: 04/27/2024
• Device Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 8035022627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown