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

Model Number	500-55112
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lytic therapy would not infuse.During a bilateral ekos case, two ekos+ devices were inserted into the patient.When the ekos+ kit 106cm 12 cm was hooked up to infuse lytic, the drug would not infuse.The drug line was aspirated in an attempt to troubleshoot the issue.The ekos+ device was replaced with an ekosonic endovascular device, 106x12cm to troubleshoot the issue, but the new ekosonic device would not infuse lytic.Once again, the drug line was aspirated in an attempt to troubleshoot the issue.As a result of the device malfunction, the physician elected to remove the ekosonic endovascular device, and the patient was transferred to the icu with only one ekos+ device in place.It was unknown whether the patient received the correct dose of lytic therapy.However, there was no reported undesirable patient outcome.
Additional Manufacturer Narrative
Device analysis: the drug lumen was hooked up to a non-boston scientific infusion pump and ran for a sustained 30 minutes of infusion.No pump error alarms were noticed.A syringe filled with blue dye was attached to the drug luer and flushed through the catheter under water.The blue dye was able to be seen coming from the drug holes and confirmed the ability of the device to be flushed.The reported event of obstruction within the drug line was unable to be confirmed.
Event or Problem Description
It was reported that the lytic therapy would not infuse.During a bilateral ekos case, two ekos+ devices were inserted into the patient.When the ekos+ kit 106cm 12 cm was hooked up to infuse lytic, the drug would not infuse.The drug line was aspirated in an attempt to troubleshoot the issue.The ekos+ device was replaced with an ekosonic endovascular device, 106x12cm to troubleshoot the issue, but the new ekosonic device would not infuse lytic.Once again, the drug line was aspirated in an attempt to troubleshoot the issue.As a result of the device malfunction, the physician elected to remove the ekosonic endovascular device, and the patient was transferred to the icu with only one ekos+ device in place.It was unknown whether the patient received the correct dose of lytic therapy.However, there was no reported undesirable patient outcome.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X12CM
• 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: 17856955
• Report Number: 2124215-2023-54030
• Device Sequence Number: 19671149
• Product Code: KRA
• UDI-Device Identifier: 00858593006134
• UDI-Public: 00858593006134
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K213422
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2023

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: 04/03/2025
• Device Model Number: 500-55112
• Device Catalogue Number: 500-55112
• Device Lot Number: 8035092217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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+ KIT 106CM 12 CM; EKOS+ KIT 106CM 12 CM
• Patient Sex: Female