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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 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.
 
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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 Key11773435
MDR Text Key249031578
Report Number2134265-2021-05376
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
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 Received05/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2022
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0025653938
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 Received04/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2020
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
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