MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOS+; CATHETER, CONTINUOUS FLUSH

Model Number	H74939605106120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 28sep2023.An ekos+ endovascular device was returned to the complaint investigation site without an associated complaint.Device analysis revealed that the coolant and drug luers were cracked and leaking.Based on the condition of the returned device, the device was used during a procedure.No further information was available.
Additional Manufacturer Narrative
B3: date of event: as the date the device was used was not reported to boston scientific, the aware date was used to estimate the event date.Device analysis: the ekos+ endovascular device was returned to the complaint investigation site.Microscopic visual inspection of the infusion catheter (ic) showed cracking on the coolant and drug port luers.The device was tested for leaking, and it was noticed that the device leaked water from the coolant and drug port luers, where the cracking was present.

• Brand Name: EKOS+
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17962443
• Report Number: 2124215-2023-57675
• Device Sequence Number: 17821500
• Product Code: KRA
• UDI-Device Identifier: 00191506015466
• UDI-Public: 00191506015466
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2023

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: 11/20/2025
• Device Model Number: H74939605106120
• Device Catalogue Number: H74939605106120
• Device Lot Number: 8035331131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown