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	11/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drug port was occluded.A 106x12cm ekosonic endovascular device was selected for use in a procedure to treat a pulmonary embolism.After a therapy run time of 12 hours, the ekos catheter was blocked to saline in the coolant port.The physician tried removing the catheter from the pa five times and washed it, but the catheter was still blocked, and saline failed to enter into the coolant port of the catheter.The drug port was also occluded, so the device was removed.The procedure continued with only one catheter in the left side of the pa.No patient complications were reported, and the patient was stable.
Additional Manufacturer Narrative
Device eval by manufacturer: the device was returned loosely tangled with the untrasonic core inserted into the infusion catheter.Some blood was seen in the device.The infusion catheter was inspected for visual damage with none found.The ultrasonic core was inspected for damage and advancement tool/pinch marks were seen 8.6cm and 58.3cm from the luer barb.Microscopic analysis of the infusion catheter showed some blockage of the drug holes due to blood.The drug port was air tested in water and bubbles were seen coming from 3 of the 12 drug holes.The device was flushed through the coolant port without issue.Saline was seen coming from the coolant holes and distal tip of the infusion catheter.The complaint was partially confirmed with the drug holes being difficult to flush; however, the coolant port had no issue with flushing.
Event or Problem Description
It was reported that the drug port was occluded.A 106x12cm ekosonic endovascular device was selected for use in a procedure to treat a pulmonary embolism.After a therapy run time of 12 hours, the ekos catheter was blocked to saline in the coolant port.The physician tried removing the catheter from the pa five times and washed it, but the catheter was still blocked, and saline failed to enter into the coolant port of the catheter.The drug port was also occluded, so the device was removed.The procedure continued with only one catheter in the left side of the pa.No patient complications were reported, and the patient was stable.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X12CM
• 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 ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16005179
• Report Number: 2124215-2022-52921
• Device Sequence Number: 5783837
• Product Code: KRA
• UDI-Device Identifier: 00858593006134
• UDI-Public: 00858593006134
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2023

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: 04/26/2024
• Device Model Number: 500-55112
• Device Catalogue Number: 500-55112
• Device Lot Number: 8035020865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male