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

Model Number	500-55112
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had to return to the cath lab for catheter replacement.Two ekosonic endovascular devices, 106x12cm were selected for use in a catheter directed thrombolysis procedure to treat a bilateral pulmonary embolism originating from a deep vein thrombosis.The 2 ekos catheters were placed with 8mg of actlyase administered on each catheter over 24hrs.After the catheters were placed, the patient was moved to the icu.The cu4.0 and cic were connected in the icu.The device kept giving an e311 error after it was connected to the 2 ekos catheters, 16 minutes after administering treatment on the first side then gave the same error on other side about an hour later.Pressures on all infusion pumps was 900mg.Infusion rate of drug port was 8.3ml/h then coolant and sheath were infusing at 41.66ml/h.The control unit was swapped for a new one, but it still gave the same error.The cics were swapped around, and new ones were used on both the old and new machine, but the same error occurred.The ultrasonic core was exchanged on one of the catheters in the icu, but the same error occurred.Ultimately, the patient was brought back to the theatre to exchange the 5fr catheter with side holes for a new one using the new ultrasonic core that was opened.The cu4.0 was fully charged then connected while using battery only power, and the unit worked.The patient was transferred to high care, and treatment resumed with no issues.When battery got to 80%, the cu4.0 was plugged into the power source, and the machine gave no errors for the remaining 24hrs of treatment.The procedure was completed with the original cu4.0, one of the original ekos catheters, and a new ekos catheter of the same size.The patient was admitted to the hospital beyond the standard of care, but the patient had good results and was stable.The patient is expected to fully recover.No patient complications were reported.
Event or Problem Description
It was reported that the patient had to return to the cath lab for catheter replacement.Two ekosonic endovascular devices, 106x12cm were selected for use in a catheter directed thrombolysis procedure to treat a bilateral pulmonary embolism originating from a deep vein thrombosis.The 2 ekos catheters were placed with 8mg of actlyase administered on each catheter over 24hrs.After the catheters were placed, the patient was moved to the icu.The cu4.0 and cic were connected in the icu.The device kept giving an e311 error after it was connected to the 2 ekos catheters, 16 minutes after administering treatment on the first side then gave the same error on other side about an hour later.Pressures on all infusion pumps was 900mg.Infusion rate of drug port was 8.3ml/h then coolant and sheath were infusing at 41.66ml/h.The control unit was swapped for a new one, but it still gave the same error.The cics were swapped around, and new ones were used on both the old and new machine, but the same error occurred.The ultrasonic core was exchanged on one of the catheters in the icu, but the same error occurred.Ultimately, the patient was brought back to the theatre to exchange the 5fr catheter with side holes for a new one using the new ultrasonic core that was opened.The cu4.0 was fully charged then connected while using battery only power, and the unit worked.The patient was transferred to high care, and treatment resumed with no issues.When battery got to 80%, the cu4.0 was plugged into the power source, and the machine gave no errors for the remaining 24hrs of treatment.The procedure was completed with the original cu4.0, one of the original ekos catheters, and a new ekos catheter of the same size.The patient was admitted to the hospital beyond the standard of care, but the patient had good results and was stable.The patient is expected to fully recover.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: device was not returned for analysis; however, analysis of the event log showed the device had a thermocouple issue that contributed to the observed failure.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X12CM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): EKOS CORP INC; 11911 n. creek parkway s.; bothell WA 98011
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15763757
• Report Number: 2124215-2022-46323
• Device Sequence Number: 6238750
• Product Code: KRA
• UDI-Device Identifier: 00858593006134
• UDI-Public: 00858593006134
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2023
• Device Model Number: 500-55112
• Device Catalogue Number: 500-55112
• Device Lot Number: 0011613608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Race: Black Or African American