MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOS ENDOVASCULAR DEVICE, 106X50CM; CATHETER, CONTINUOUS FLUSH

Lot Number 8035106441

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

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

Event Date 12/23/2023

Event Type  Injury  

Event Description

It was reported that the ultrasonic core fractured and migrated, requiring intervention.This 106x50cm ekosonic endovascular device was selected for use in an iliofemoral deep vein thrombosis procedure.The ekos catheter was inserted from the popliteal to the inferior vena cava (ivc) and an e311 error message was subsequently observed.Troubleshooting was unable to resolve the error; therefore, the catheter was used as an infusion catheter for the delivery of lytic.After approximately 20 hours, a follow up venogram was performed which revealed that the ultrasonic core had fractured around the thigh area and migrated to the patients ivc.The piece was snared from the patient and the procedure was completed using an alternate device.There were no patient complications.

Manufacturer Narrative

Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, visual analysis found that the ultrasonic core (usc) was broken at approximately 63cm from the luer barb.Additionally, cracks in the coolant and drug luer of the infusion catheter (ic) were observed.Leakage testing of the luers confirmed that the luers also leaked liquid from the cracks.Functional testing of the usc confirmed that multiple alarms displayed on the cu4.0 because of the broken usc wire.

Event Description

It was reported that the ultrasonic core fractured and migrated, requiring intervention.This 106x50cm ekosonic endovascular device was selected for use in an iliofemoral deep vein thrombosis procedure.The ekos catheter was inserted from the popliteal to the inferior vena cava (ivc) and an e311 error message was subsequently observed.Troubleshooting was unable to resolve the error; therefore, the catheter was used as an infusion catheter for the delivery of lytic.After approximately 20 hours, a follow up venogram was performed which revealed that the ultrasonic core had fractured around the thigh area and migrated to the patients ivc.The piece was snared from the patient and the procedure was completed using an alternate device.There were no patient complications.

• Brand Name: EKOS ENDOVASCULAR DEVICE, 106X50CM
• 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: 18526005
• MDR Text Key: 333035315
• Report Number: 2124215-2023-73726
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 8035106441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 03/01/2024
• Supplement Dates FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention