MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X50CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-56150
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had to return to the catheterization lab for device replacement.An ekos endovascular device, 135x50cm was selected for use.The device was installed in the patient with no complications or defects noted.The patient was sent to the icu.After approximately 45 minutes of treatment in the icu, it was noted that the catheter was leaking at the hub and the physician was notified.It was undetermined whether the leak was from the drug line or the coolant line.The patient was brought back to the catheterization lab and the ekos endovascular device was removed and replaced with a new one.There were no adverse consequences reported to the patient.The patient fully recovered.
Event or Problem Description
It was reported that the patient had to return to the catheterization lab for device replacement.An ekos endovascular device, 135x50cm was selected for use.The device was installed in the patient with no complications or defects noted.The patient was sent to the icu.After approximately 45 minutes of treatment in the icu, it was noted that the catheter was leaking at the hub and the physician was notified.It was undetermined whether the leak was from the drug line or the coolant line.The patient was brought back to the catheterization lab and the ekos endovascular device was removed and replaced with a new one.There were no adverse consequences reported to the patient.The patient fully recovered.
Additional Manufacturer Narrative
This supplemental report was not able to be submitted on-time by boston scientific because of delayed acknowledgments from fda for the initial report.An fda system issue resulted in the delayed acknowledgements.This report will not be considered late, because it was the result of an fda system issue.Device media analysis: during visual inspection and measurement, it was noticed that the ic measured 139cm, which is over the expected size range for a normal 135cm ekos ic.Microscopic visual inspection of usc and ic showed no significant kinking or pinching.However, it was noticed that the wire was slightly wavy, as if it had been stretched.The device was tested for leaks.It was noticed that the device leaked from the drug lumen out of the tip of the strain relief.The hub was disassembled, and the strain relief was removed to pinpoint the leak.The leak appeared to be coming from the hub section just before the strain relief.The reported event of a leak from the catheter hub was confirmed.Updated fields: d4: model number, lot number, catalog number, expiration date, serial number, unique identifier (udi) #.G1: manufacturing site, manufacturer contact person.H4: device manufacture date.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 135X50CM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela MA ; CS
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16518372
• Report Number: 2124215-2023-10917
• Device Sequence Number: 20365683
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K182324
• 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): 04/21/2023

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 Expiration Date: 02/27/2025
• Device Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 8035086235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2022
• 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 Sex: Unknown