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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK JETSTREAM® XC ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY

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BOSTON SCIENTIFIC - CORK JETSTREAM® XC ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 112264-003
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Embolism (1829)
Event Date 06/26/2018
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).
 
Event Description
The patient was enrolled in (b)(6) study. It was reported that a distal embolism occurred. The jetstream system was used for an atherectomy procedure in the anterior tibial artery, following percutaneous transluminal angioplasty (pta). During the index procedure, a distal embolization was detected through angiography in the target limb. The embolization was treated with endovascular pta and thrombus aspiration. The same day the event was considered to be resolved following treatment.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that the target lesion was the right mid superficial femoral artery. The target lesion was 100% stenosed and had a reference diameter of 4mm, a length of 60mm, and was classified as a tasc ii a lesion. A 2. 1mm jetstream xc atherectomy catheter was selected for use for the atherectomy procedure. A 1. 85 jetstream xc atherectomy catheter was also used for treatment during the procedure. Residual stenosis following use of the jetstream was 20%. After post-treatment percutaneous transluminal angioplasty was performed, residual stenosis was 0%.
 
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Brand NameJETSTREAM® XC ATHERECTOMY CATHETER
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork MN
EI
Manufacturer (Section G)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7733254
MDR Text Key115521435
Report Number2134265-2018-06718
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
K130637
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 07/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/14/2019
Device Model Number112264-003
Device Catalogue NumberPV31300
Device Lot Number21375755
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 Received07/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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