MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X24CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-55124
Medical Device Problem Codes	Leak/Splash (1354); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a drug leak and occlusion.An ekosonic endovascular device, 106x24cm was selected for use in a unilateral thrombolysis procedure.After seven hours of ekos therapy, while in the icu, it was observed that there was a wet spot in the patient's bed and some blood backing up in the drug luer.The nurse attempted to flush the catheter and observed that fluid squirted sideways out of the drug infusion tubing, below the hub where the stopcock was connected.There was a pinhole leak in the hub of the drug infusion tubing.The line into the patient was completely occluded.Troubleshooting was unable to resolve the issue.The tpa was run at a slower rate to bypass the issue and therapy was completed in the morning.Thrombus was resolved.There were no reported adverse consequences to the patient.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X24CM
• 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: 20523485
• Report Number: 2124215-2024-66756
• Device Sequence Number: 18138458
• Product Code: KRA
• UDI-Device Identifier: 00858593006158
• UDI-Public: 00858593006158
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 10/24/2024

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: 05/09/2025
• Device Model Number: 500-55124
• Device Catalogue Number: 500-55124
• Device Lot Number: 8035099180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2024
• Initial Report FDA Received Date: 10/24/2024
• Date Device Manufactured: 05/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown