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

Model Number	H74939605106120
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the drug port leaked, requiring an additional device.One 106cm 12 cm ekos plus catheter and one 135cm 16 cm ekos plus catheter were selected for use.During the procedure, both ekos catheters were placed in the patient and hooked up to the appropriate pumps.After everything was connected, it was determined that one of the catheters had moved inside the patient and needed to be repositioned.All lines were then disconnected, the catheter was repositioned and everything was hooked back up again.The patient was moved to the intensive care unit (icu) and it was noticed that both drug lumen ports were leaking fluid at the connector.The patient was brought back to the lab and the original catheters were removed and two new ekos catheters were placed without issue.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: the ekos+ kit 106cm 12 cm was returned for analysis.Microscopic visual inspection of the infusion catheter (ic) showed that the drug luer displayed cracking.The device was tested using a syringe filled with water to flush the line.During the line flush, the drug luer began to leak.It was noticed that the device leaked from the crack on the drug luer.
Event or Problem Description
It was reported that the drug port leaked, requiring an additional device.One 106cm 12 cm ekos plus catheter and one 135cm 16 cm ekos plus catheter were selected for use.During the procedure, both ekos catheters were placed in the patient and hooked up to the appropriate pumps.After everything was connected, it was determined that one of the catheters had moved inside the patient and needed to be repositioned.All lines were then disconnected, the catheter was repositioned and everything was hooked back up again.The patient was moved to the intensive care unit (icu) and it was noticed that both drug lumen ports were leaking fluid at the connector.The patient was brought back to the lab and the original catheters were removed and two new ekos catheters were placed without issue.There were no patient complications.

• 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: 19793615
• Report Number: 2124215-2024-44493
• Device Sequence Number: 4133904
• Product Code: KRA
• UDI-Device Identifier: 00191506015466
• UDI-Public: 00191506015466
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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 Model Number: H74939605106120
• Device Catalogue Number: H74939605106120
• Device Lot Number: 8035930531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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: 1 MO
• Patient Sex: Female