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

Model Number	500-55112
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a drug leak.A 106x12cm ekosonic endovascular device was selected for use in a bilateral pulmonary embolism case.After 11 of the 12 hours of ordered therapy time, it was observed that the drug luer had blood backing up into it, and there was small hole in the luer leaking tpa.The physician decided to pull the catheter.The patient did well.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: the ekosonic endovascular device was returned for analysis.Microscopic visual inspection of the infusion catheter showed a crack in the drug luer.The device was tested for leaking, and it was noticed that the device leaked from the drug luer where the crack was present.The coolant luer was not cracked or leaking.Additionally, it was found that the rubber tubing attached to the luers was deformed, creating an angle of the luers.This bend did not affect product performance.
Event or Problem Description
It was reported that there was a drug leak.A 106x12cm ekosonic endovascular device was selected for use in a bilateral pulmonary embolism case.After 11 of the 12 hours of ordered therapy time, it was observed that the drug luer had blood backing up into it, and there was small hole in the luer leaking tpa.The physician decided to pull the catheter.The patient did well.No patient complications were reported.

• 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: 20145661
• Report Number: 2124215-2024-53358
• Device Sequence Number: 4247877
• Product Code: KRA
• UDI-Device Identifier: 00858593006134
• UDI-Public: 00858593006134
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/02/2024

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: 500-55112
• Device Catalogue Number: 500-55112
• Device Lot Number: 8035279402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown