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

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

Patient Problem Embolism/Embolus (4438)

Event Date 05/24/2023

Event Type  Injury  

Event Description

Elegance clinical study it was reported than an embolism occurred.The subject underwent treatment with the ranger drug coated balloon on (b)(6)2023 as a part of the elegance clinical trial.The target lesion was in right distal superficial femoral artery (sfa) with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length of 400 mm and 70% stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment with study device, atherectomy was performed using 5 mm x 200 mm jetstream 2.4/3.4 atherectomy device.Treatment of target lesion was performed by dilation using study device, 5 mm x 150 mm ranger drug coated balloon.Post treatment, the final residual stenosis was noted to be 5%.On (b)(6)2023, on the same day of index procedure, during the treatment of the target lesion, embolism was noted in the right popliteal artery due to 5 mm x 200 mm jetstream 2.4/3.4 atherectomy device.As a response to the complication, balloon dilation and cdt urokinase were performed.Post treatment, the final residual stenosis was noted to be 5%.The complication of embolism was resolved.On (b)(6) 2023, the subject was discharged on clopidogrel.

Manufacturer Narrative

A1 - patient identifier: (b)(6).Age at time of enrollment: 67 years old.

• Brand Name: JETSTREAM ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17430421
• MDR Text Key: 320112834
• Report Number: 2124215-2023-39601
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/31/2023

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 07/31/2023
• 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
• Patient Sex: Female
• Patient Race: Asian