MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X40CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-55140
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Chest Pain (1776); Pericardial Effusion (3271)
Date of Event	06/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ultrasonic core broke off inside the patient requiring surgical removal.On (b)(6) 2024, the patient presented with thoracic outlet syndrome and underwent a catheter-directed thrombolysis procedure with a 40 cm x 106 cm ekos catheter.The catheter was placed in the left subclavian vein.It was noted that a 24 cm x 106 cm ekos catheter and a 40 cm x 106 cm ekos catheter were used or assigned to this patient.Following catheter placement, the patient was admitted to the intensive care unit (icu) for thrombolytic infusion.There were no reported issues encountered at the time of the procedure.Following overnight thrombolysis via the ekos catheter, the patient returned to the catheterization laboratory on (b)(6) 2024 for a catheter check.Reportedly this was uneventful, and the ekos catheter was removed over a wire.The patient underwent balloon angioplasty of the left subclavian vein.The patient was discharged, and five to six days later underwent left first rib resection and release of the thoracic outlet.On (b)(6) 2024, the patient was admitted to a different facility with chest pain.Computed tomography (ct) imaging revealed a foreign body within the inferior vena cava (ivc) and right atrium/ventricle.The foreign body was determined to be approximately 35 cm of the ekos ultrasound core wire.The physician performed a foreign body retrieval and was able to snare out approximately 30 cm of the ultrasound core.A 5 cm fractured fragment was unable to be retrieved endovascularly.Following the procedure, the patient was still experiencing chest pain and was found to have a moderate-sized pericardial effusion.The patient underwent an additional attempt at endovascular retrieval by an electrophysiologist (ep) physician which was unsuccessful.On (b)(6) 2024, the patient underwent open heart surgery to remove the fragment which was behind the anterior leaflet of the tricuspid valve.The valve was subsequently repaired.The patient also underwent treatment of the hemopericardium with drainage of 250-300 ml of blood from the pericardial space.The patient is currently recovering, stable, and in good condition now.The patient was expected to fully recover.
Additional Manufacturer Narrative
Media analysis: the device was not returned for analysis; however, media was reviewed.Event logs from the console were provided.It was noted that a 106x24cm infusion catheter and a 106x40cm ultrasonic core were initially connected to the console.This resulted in an incompatibility error.The user repeatedly connected and disconnected the same incompatible infusion catheter and ultrasonic core.The user then removed the 106x40cm ultrasonic core, left the 106x24cm infusion catheter connected, and connected a new 106x24cm ultrasonic core.
Event or Problem Description
It was reported that the ultrasonic core broke off inside the patient requiring surgical removal.On (b)(6) 2024, the patient presented with thoracic outlet syndrome and underwent a catheter-directed thrombolysis procedure with a 40 cm x 106 cm ekos catheter.The catheter was placed in the left subclavian vein.It was noted that a 24 cm x 106 cm ekos catheter and a 40 cm x 106 cm ekos catheter were used or assigned to this patient.Following catheter placement, the patient was admitted to the intensive care unit (icu) for thrombolytic infusion.There were no reported issues encountered at the time of the procedure.Following overnight thrombolysis via the ekos catheter, the patient returned to the catheterization laboratory on (b)(6) 2024 for a catheter check.Reportedly this was uneventful, and the ekos catheter was removed over a wire.The patient underwent balloon angioplasty of the left subclavian vein.The patient was discharged, and five to six days later underwent left first rib resection and release of the thoracic outlet.On (b)(6) 2024, the patient was admitted to a different facility with chest pain.Computed tomography (ct) imaging revealed a foreign body within the inferior vena cava (ivc) and right atrium/ventricle.The foreign body was determined to be approximately 35 cm of the ekos ultrasound core wire.The physician performed a foreign body retrieval and was able to snare out approximately 30 cm of the ultrasound core.A 5 cm fractured fragment was unable to be retrieved endovascularly.Following the procedure, the patient was still experiencing chest pain and was found to have a moderate-sized pericardial effusion.The patient underwent an additional attempt at endovascular retrieval by an electrophysiologist (ep) physician which was unsuccessful.On (b)(6) 2024, the patient underwent open heart surgery to remove the fragment which was behind the anterior leaflet of the tricuspid valve.The valve was subsequently repaired.The patient also underwent treatment of the hemopericardium with drainage of 250-300 ml of blood from the pericardial space.The patient is currently recovering, stable, and in good condition now.The patient was expected to fully recover.It was further reported that on (b)(6) 2024, the first 24cm ekos catheter was not long enough and therefore removed.Reportedly, the 24cm ultrasonic core was never placed.Subsequently, a 40cm ekos catheter was placed followed by the ultrasonic core without issue.The patient was transferred to the icu.The physician does not recall any issues removing the ultrasonic core on (b)(6) 2024.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X40CM
• Common Device Name: 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: 19667679
• Report Number: 2124215-2024-40776
• Device Sequence Number: 12448923
• Product Code: KRA
• UDI-Device Identifier: 00858593006172
• UDI-Public: 00858593006172
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K213422
• 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): 08/07/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2026
• Device Model Number: 500-55140
• Device Catalogue Number: 500-55140
• Device Lot Number: 8035444431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 08/07/2024
• Date Device Manufactured: 02/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female