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

Model Number 500-56150

Device Problems Leak/Splash (1354); Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2023

Event Type  Injury  

Event Description

It was reported that there was a drug leak and occlusion.A 135x50cm ekosonic endovascular device was selected for use in a lower extremity procedure.The catheter was placed, and infusion began.After 9.5 hours of therapy, it was reported that the drug port was leaking at the hub, and blood was coming back up the tubing causing an occlusion.Attempts were made to flush and change the stopcock, but the leak was still occurring.It was decided to discontinue the drip and bring the patient back to reevaluate and attempt to fix the thrombus burden in the vessel.The patient was brought back to the cath lab, and flow was restored using alternative measures that included angiojet and balloon angioplasty.No patient complications were reported.

Manufacturer Narrative

Device eval by manufacturer: the ekosonic endovascular device was returned for analysis.Microscopic visual inspection of the infusion catheter showed cracking on the drug port and coolant luer.Kinking of the infusion catheter was noticed at 16cm and 115 cm from the strain relief.Kinking of the ultrasonic core was noticed at 122cm from the luer barb.The device was tested for leaking, and it was noticed that the device leaked water from the drug port and coolant luer where the cracking was present.The device was unable to be flushed because of the cracked luers causing leakage.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 135X50CM
• Type of Device: 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16997142
• MDR Text Key: 315883765
• Report Number: 2124215-2023-25981
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 8035287071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Race: White