MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X50CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-55150
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via attached voluntary medwatch/maude report list #mw5158934 that there was a drug leak.An ekosonic endovascular device, 106x50cm was selected for use.During the procedure, when tpa administration was started, a small leak was discovered in the catheter.No further details were available, despite request by boston scientific.
Event or Problem Description
It was reported via attached voluntary medwatch/maude report list #mw5158934 that there was a drug leak.An ekosonic endovascular device, 106x50cm was selected for use.During the procedure, when tpa administration was started, a small leak was discovered in the catheter.No further details were available, despite request by boston scientific.
Additional Manufacturer Narrative
Updated fields: h6 - evaluation result codes, evaluation conclusion codes.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X50CM
• 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: 20441985
• Report Number: 2124215-2024-64064
• Device Sequence Number: 20839593
• Product Code: KRA
• UDI-Device Identifier: 00858593006189
• UDI-Public: 00858593006189
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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 Expiration Date: 06/14/2025
• Device Model Number: 500-55150
• Device Catalogue Number: 500-55150
• Device Lot Number: 8035107031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/08/2024
• Date Device Manufactured: 06/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic