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

Model Number 500-56150

Device Problems Device Alarm System (1012); Obstruction of Flow (2423)

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

Event Date 05/31/2023

Event Type  malfunction  

Event Description

It was reported that a drug occlusion occurred.A 135x50cm ekosonic endovascular device was selected for use in thrombolytic therapy of a peripheral arterial occlusion.After 8 hours and 21 minutes of therapy run time, the pump was alarming with a downstream occlusion (dso) to the tpa line.The registered nurse (rn) called the helpline and reported that the patient's iv line had been intermittently giving a dso to the tpa line over the last few hours.The frequency had been increasing, and at the time of the call, it had stopped running.Troubleshooting was attempted but was unsuccessful.The rn tried to obtain orders to flush the catheter forward.However, after 1.5 hours, they were instructed to stop tpa and discontinue ultrasound and use of the catheter.No patient complications were reported.At the time of the call, the patient was restless but tolerating therapy well.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17210927
• MDR Text Key: 317951905
• Report Number: 2124215-2023-33359
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 211231287-331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1