MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM XC; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 45007

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Obstruction/Occlusion (2422); Vascular Dissection (3160); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 10/03/2023

Event Type  Injury  

Event Description

It was reported that dissection, distal embolization, and thrombotic occlusion occurred, and the patient had a subsequent amputation.On 26-sep-2023, this 2.4mm jetstream xc catheter was selected for use in an endovascular therapy procedure.The 75% stenosed, severely calcified, moderately tortuous lesion was located in the right superficial femoral artery (sfa).During the procedure, this jetstream device was used to perform lesion ablation with 2 to 3 passes in blades down, and 2 to 3 passes in blades up.After confirming that sufficient ablation was performed and no major problems occurred such as dissection during contrast imaging, the lesion was dilated with a ranger 6.0/200mm balloon.The procedure was then completed after confirming that there was good dilatation, and no major problems were noticed during final angiography.Final contrast imaging was performed; however, the contrast was unable to reach the toes.Several days post procedure, the patient complained of pain in the right lower extremity.Contrast imaging revealed the common femoral artery was thrombotic and occluded; therefore, the patient was transferred to the hospital.They attempted to improve blood flow with a non-boston scientific device for thrombotic occlusion.However, the expected result was not obtained; therefore, the patient was transferred to a different hospital and underwent a major amputation on 20-oct-2023.It was later reported that thrombus occurred because the lesion in the sfa ostium was not treated.It was also reported that a dissection had formed in the area cut with the jetstream device which had been overlooked, and a blood clot formed in that area.Additionally, there was a distal embolization at a level that was not visible to the naked eye, and due to a combination of factors, the distal embolization progressed to thrombotic occlusion.

Manufacturer Narrative

The complaint device was not received at the complaint investigation site (cis) for analysis.Medical and media review of angiogram performed on 9/26/2023 at the time of the jetstream procedure, and the follow up angiogram on 10/14/2023, was completed.Arteriography performed on 9/26/2023, shows no below knee runoff was provided, but flow on the images appear adequate.Arteriography on 10/14/2023 demonstrates complete occlusion of the right cfa and no infrainguinal artery opacification.There is no evidence of distal embolization on any of the arteriograms provided.As a result, of the medical and media review, distal embolization cannot be confirmed.

• Brand Name: JETSTREAM XC
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18156285
• MDR Text Key: 328351901
• Report Number: 2124215-2023-61200
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: 08714729889922
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133023
• 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
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RANGER, JUPITER FC
• Patient Outcome(s): Required Intervention; Other