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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM PVCN100 CATHETER, PERIPHERAL, ATHERECTOMY

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BOSTON SCIENTIFIC CORPORATION JETSTREAM PVCN100 CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45010
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 06/28/2018
Event Type  Injury  
Event Description
It was reported that the patient experienced superficial femoral artery distal dissection after percutaneous transluminal angioplasty (pta). The patient was enrolled in the (b)(6) study with the patient identifier of (b)(6) on (b)(6) 2018. A target lesion located in the right distal superficial femoral artery (sfa). The lesion was 100% occluded with a reference vessel diameter of 4 mm, length of 50 mm and was classified as a tasc ii b lesion. The target lesion was treated with a 2. 1 mm jetstream xc atherectomy catheter and jetstream console. Post treatment, pta was performed, with 0% final residual stenosis. On (b)(6) 2018, same day of the index procedure post pta, dissection in the distal sfa was noted. This event could possibly be related to the jetstream devices. On (b)(6) 2018, the event was considered recovered/resolved. The patient had been discharged by (b)(6) 2018 with aspirin and clopidogrel. No action was taken to treat the event. No further complications were reported.
 
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Brand NameJETSTREAM PVCN100
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
47215 lakeview boulevard
fremont CA 94538
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8461292
MDR Text Key140207432
Report Number2134265-2019-03068
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K082664
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 03/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number45010
Device Catalogue Number45010
Device Lot NumberJET0558
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 Received03/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/03/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/28/2019 Patient Sequence Number: 1
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