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

Model Number 45007

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

Patient Problem Vascular Dissection (3160)

Event Date 04/09/2021

Event Type  Injury  

Event Description

It was reported that a vessel dissection occurred, requiring additional intervention. On (b)(6) 2021, the subject was enrolled into (b)(6) study and the index procedure was performed on the same day. A target lesion located in the right distal superficial femoral artery (sfa) had 95% occlusion, reference vessel diameter of 4mm, length of 30mm, and it was classified as a tasc ii a lesion. The target lesion was treated with a 2. 1/3. 0mm jetstream catheter. The residual stenosis post jetstream atherectomy was 100%. Post treatment, percutaneous transluminal angioplasty (pta) was performed, with 0% final residual stenosis. On (b)(6) 2021, during the index procedure, the subject was noted with unknown f-type dissection. Pta and stenting were performed in the target vessel as action taken to treat the event. On (b)(6) 2021, the event was considered to be recovered/resolved.

• Brand Name: JETSTREAM XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11773435
• MDR Text Key: 249031578
• Report Number: 2134265-2021-05376
• 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: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/31/2022
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0025653938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2020
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/04/2021 Patient Sequence Number: 1