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 Problems Pain (1994); Vascular Dissection (3160)

Event Date 03/23/2021

Event Type  Injury  

Event Description

It was reported that the patient experienced pain, and the jetstream either dissected the vessel or potentially entered the subintimal space.A 2.4mm jetstream xc atherectomy catheter was selected for use in an atherectomy procedure to treat a chronic total occlusion (cto) in the superficial femoral artery (sfa).Intravascular ultrasound (ivus) was used prior to jetstream, and the physician believed that the ivus device was in the true lumen.A non-boston scientific filter wire was used.The jetstream was used in blades down mode initially followed by blades up mode, which is when the patient commented on some pain.There was no pain in blades down mode.After using the jetstream device, it appeared that a dissection occurred in the sfa just above the location where the jetstream was used based on ivus.However, there was speculation that it was not a dissection, and the device crossed some subintimal space.Angioplasty was then performed with a non-boston scientific balloon followed by a 5mm x 100mm x 135cm ranger drug-coated balloon.The procedure was successfully completed.The patient was expected to fully recover.

• 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: 11639482
• MDR Text Key: 244616384
• Report Number: 2134265-2021-03986
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2021

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
• Device Expiration Date: 10/24/2022
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0026407731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ABBOTT NAV 6 FILTER AND BAREWIRE
• Patient Outcome(s): Required Intervention