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	02/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient returned to the catheterization lab to replace the catheter.An ekos endovascular device, 106x12cm was selected for unilateral use.The catheter was placed in the pulmonary artery, at which point lysis, coolant, and ultrasound were initiated.The patient was moved to the icu for continued therapy.After approximately 45 minutes, an error e311 was observed on the control unit (cu).Troubleshooting steps included flushing the catheter, exchanging the catheter interface cable (cic), and connecting the cic to a different cu channel, none of which resolved the error message.Catheter connections were confirmed to be dry with no bent pins.As troubleshooting was unsuccessful, the patient returned to the catheterization lab and the ekos endovascular device was replaced.Following catheter replacement, the error e311 was still observed on the cu.Therapy was completed by using the second ekos endovascular device as a standard infusion catheter without the use of ultrasound.The procedure outcome was good without the use of ultrasound.There were no reported adverse consequences to the patient.

• 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: 16424709
• Report Number: 2124215-2023-06720
• Device Sequence Number: 5543486
• Product Code: KRA
• UDI-Device Identifier: 00858593006134
• UDI-Public: 00858593006134
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K183361
• 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): 02/22/2023

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: 10/12/2023
• Device Model Number: 500-55112
• Device Catalogue Number: 500-55112
• Device Lot Number: 0011524126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EKOS ENDOVASCULAR DEVICE; EKOSONIC CONTROL UNIT 4.0
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown