MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X40CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-56140
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 21 aug 2024.It was reported that there was insufficient output.A 135x40cm ekosonic endovascular device was selected for a periacetabular osteotomy (pao) right leg and sheath to left groin procedure.Coolant was administered at 35ml/hr and drug was at 1mg/hr.Approximately 4 hours into therapy run time, there was a red x msd alarm followed by an ekos waves and red x alarm.The nurse confirmed that the msd was properly seated.No bent pins or fluid ingress were noted.Toggle switch was turned off for 30 seconds, and the nurse pressed start.The alarm returned with box with red x ekos waves.All msd groups disabled.The nurse went through checking msd again.It was decided to run the catheter as a plain infusion catheter to complete the procedure.There were no patient complications reported.However, device analysis revealed the drug luer was cracked and leaking.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the ekos device was returned for analysis.The ekos device was observed visually for abnormalities, and it was found that the ultrasonic core (usc) was significantly kinked approximately 2cm from the luer barb and appeared to have charred wiring.The infusion catheter (ic) was significantly kinked at approximately 29cm and 37cm from the strain relief.Additionally, the drug luer was cracked.The device was leak tested, and it was found that the device leaked from the drug luer where the cracking was present.The device was tested for functionality on the cu4.0 console, and an e311 alarm, indicating all ultrasonic groups disabled appeared 30 seconds into therapy.The reported event of the error alarm was confirmed.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 135X40CM
• 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: 20129618
• Report Number: 2124215-2024-55002
• Device Sequence Number: 18013034
• Product Code: KRA
• UDI-Device Identifier: 00858593006301
• UDI-Public: 00858593006301
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/03/2024

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 Model Number: 500-56140
• Device Catalogue Number: 500-56140
• Device Lot Number: 8035269352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown