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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION JETSTREAM XC ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
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.
 
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Brand NameJETSTREAM XC ATHERECTOMY CATHETER
Type of DeviceCATHETER, 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 Key11639482
MDR Text Key244616384
Report Number2134265-2021-03986
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0026407731
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 Received03/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/23/2020
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: 04/09/2021 Patient Sequence Number: 1
Treatment
ABBOTT NAV 6 FILTER AND BAREWIRE
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