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

Model Number	500-56130
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 04aug2022.It was reported that an error message occurred.An 135x30cm ekosonic catheter was selected for use to treat a unilateral deep vein thrombus.The therapy run time with the catheter was 13 hours and five minutes.At that point, an alarm occurred which indicated that the device temperature was too high.Troubleshooting was performed by the nurse and was resolved.However, the same error occurred again.Additional troubleshooting was performed but that did not resolve the issue.The nurse consulted with the physician who decided to turn off the ekos ultrasound and run the catheter as a simple infusion catheter.The procedure was completed.There were no patient complications.However, device analysis revealed a fractured catheter.
Additional Manufacturer Narrative
Device eval by mfr: the device was received and analysis was completed on 04aug2022.The ultrasonic catheter (usc) was returned severed 119.5cm from the luer barb.The severed section was not found in the return package.The infusion catheter (ic) was received full of blood up into the coolant and drug ports.A severe kink was found on the ic that lined up with the separation of the usc.The ic and usc were connected and plugged into an inhouse cu4.0 console.Analysis of the in-house event log showed the device received a temperature alert, soon after treatment started, and the alarm continued for the entire run time of 38 minutes.

• 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: 15282690
• Report Number: 2134265-2022-08566
• Device Sequence Number: 2406833
• Product Code: KRA
• UDI-Device Identifier: 00858593006295
• UDI-Public: 00858593006295
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 08/24/2022

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: 01/04/2025
• Device Model Number: 500-56130
• Device Catalogue Number: 500-56130
• Device Lot Number: 8035074175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown