MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X30CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-56130
Medical Device Problem Codes	Break (1069); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ultrasonic core broke.A 135x30cm ekosonic endovascular device was selected for use in a unilateral arterial procedure.On the second day running, the catheter was exchanged out for a new catheter in the operating room.After less than 30 minutes of therapy runtime, e311 and e300 alarms occurred.The helpline was called, and troubleshooting was unsuccessful.Options were given to either run as catheter directed thrombolysis (cdt) or to switch out the catheter for a new one.Ultimately, the patient was taken back to the operating room to switch out the catheter.When removing the catheter, it was observed under fluoroscopy that a portion of the ultrasonic core was floating around in the patient's inferior vena cava.The physician was able to snare and retrieve the device fragment.A new catheter was placed, and the patient was stable.The patient was okay and treated for additional disease.
Additional Manufacturer Narrative
Device eval by manufacturer: an ekosonic catheter and ultrasonic core were returned for analysis.The cables of both were returned cut from the device.Visual analysis of the device showed that the infusion catheter had blood in the drug lumens and some kinks and a flattened section.Visual analysis of the ultrasonic core showed that the device had become separated and had some kinking on the returned separated piece.Microscopic analysis of the infusion catheter found kinks at 0.8cm and 34.1cm from the end of the strain relief.A flattened section of the infusion catheter was found at 106cm from the strain relief and was 2cm in length.Microscopic analysis of the ultrasonic core found pinch marks 11.3cm and 62.7cm from the luer barb.The ultrasonic core was separated into three pieces; two pieces were returned.The device was separated at 111.5cm from the luer barb.The separated length was 21.2cm long.The device had another separation at the end of this length, and this 9cm section of the ultrasonic core was not returned.The e300 and e311 alarms were unable to be confirmed due to the cables being cut from the devices.
Event or Problem Description
It was reported that the ultrasonic core broke.A 135x30cm ekosonic endovascular device was selected for use in a unilateral arterial procedure.On the second day running, the catheter was exchanged out for a new catheter in the operating room.After less than 30 minutes of therapy runtime, e311 and e300 alarms occurred.The helpline was called, and troubleshooting was unsuccessful.Options were given to either run as catheter directed thrombolysis (cdt) or to switch out the catheter for a new one.Ultimately, the patient was taken back to the operating room to switch out the catheter.When removing the catheter, it was observed under fluoroscopy that a portion of the ultrasonic core was floating around in the patient's inferior vena cava.The physician was able to snare and retrieve the device fragment.A new catheter was placed, and the patient was stable.The patient was okay and treated for additional disease.It was further reported that the procedure was for an illio femoral inferior vena cava deep vein thrombosis.It was a pop stick initially then they went in through the ij to fish the floating 9cm piece out.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 135X30CM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16098948
• Report Number: 2124215-2022-55902
• Device Sequence Number: 12443087
• Product Code: KRA
• UDI-Device Identifier: 00858593006295
• UDI-Public: 00858593006295
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K182324
• 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,Followup
• Report Date (Section B): 03/07/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2025
• Device Model Number: 500-56130
• Device Catalogue Number: 500-56130
• Device Lot Number: 8035169921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown