MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTROL UNIT 4.0; CATHETER, CONTINUOUS FLUSH

Model Number	600-40500
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.During a bilateral ekos procedure, the control unit 4.0 started alarming with an e311 error on both catheters.Troubleshooting was performed but was unable to resolve the alarm.The ekos therapy was discontinued approximately three hours after the treatment started.There were no reported patient complications.
Event or Problem Description
It was reported that the procedure was cancelled.During a bilateral ekos procedure, the control unit 4.0 started alarming with an e311 error on both catheters.Troubleshooting was performed but was unable to resolve the alarm.The ekos therapy was discontinued approximately three hours after the treatment started.There were no reported patient complications.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this ekos control unit 4.0 was received in good condition.Internal visual inspection found no internal damage.Functional tests were performed which revealed no errors.The clinical observations were not confirmed.
Event or Problem Description
It was reported that the procedure was cancelled.During a bilateral ekos procedure, the control unit 4.0 started alarming with an e311 error on both catheters.Troubleshooting was performed but was unable to resolve the alarm.The ekos therapy was discontinued approximately three hours after the treatment started.There were no reported patient complications.

• Brand Name: CONTROL UNIT 4.0
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): EKOS CORP INC; 11911 n. creek parkway s.; bothell WA 98011
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20089455
• Report Number: 2124215-2024-53608
• Device Sequence Number: 20747062
• Product Code: KRA
• UDI-Device Identifier: 00858593006462
• UDI-Public: 00858593006462
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2025

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 Model Number: 600-40500
• Device Catalogue Number: 600-40500
• Device Lot Number: 0011242426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 09/03/2024; 02/18/2025
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/09/2024; 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown