MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOS ENDOVASCULAR DEVICE, 106X12CM; CATHETER, CONTINUOUS FLUSH

Lot Number 8035792741

Device Problems Obstruction of Flow (2423); Output Problem (3005)

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

Event Date 01/27/2024

Event Type  Injury  

Event Description

It was reported that there was an unresolved drug occlusion requiring catheter exchange.An ekos endovascular device, 106x12cm was selected for use to treat a bilateral pulmonary embolism.Shortly after the device was placed, connections were being secured.Once the drug line was hooked up to the non-boston scientific infusion pump and the lytic therapy was being administered, there was a dso (downstream occlusion) alert on the infusion pump.Flushing the drug line with a 1cc syringe was unsuccessful in dislodging the occlusion.The drug line was able to be flushed with a 3cc syringe, but the alert on the infusion pump persisted.Troubleshooting was unable to resolve the alert.As a result, the patient was returned from the icu to the catheterization lab, and the ekos device was exchanged to resolve the issue.When the new ekos device was being connected, and e325 alarm appeared on the control unit.Investigation revealed that the original ekos device that was no longer inside the patient had been inadvertently connected to the control unit.The new ekos device was connected, and the alarm resolved.There were no reported patient consequences, and the patient was reported to be stable.

• Brand Name: EKOS ENDOVASCULAR DEVICE, 106X12CM
• 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
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18740417
• MDR Text Key: 335770663
• Report Number: 2124215-2024-09723
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 8035792741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2024
• 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
• Patient Outcome(s): Required Intervention