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	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event estimated using aware date.Device eval by manufacturer: the ekosonic endovascular device was returned for analysis.Upon initial inspection, the infusion catheter was completely occluded with dried blood, and the coolant and drug ports were unable to be flushed.The infusion catheter was soaked in a warm water bath to loosen the dried blood that was occluding the catheter.After the warm water bath, the coolant lumen was able to be flushed.However, after multiple attempts, the drug port was unable to be flushed.Microscopic visual inspection showed that the drug holes in the infusion catheter were completely occluded with dried blood, which likely led to the inability to flush the drug line.
Event or Problem Description
It was reported that there was a drug delivery issue.A 106x12cm ekosonic endovascular device was selected for use in a procedure to treat a pulmonary embolism.During preparation, it was found the tpa part of the catheter was not working.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: 18388918
• Report Number: 2124215-2023-73056
• Device Sequence Number: 4020481
• Product Code: KRA
• UDI-Device Identifier: 00858593006134
• UDI-Public: 00858593006134
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2023

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: 09/06/2026
• Device Model Number: 500-55112
• Device Catalogue Number: 500-55112
• Device Lot Number: 8035782131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown