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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM PV ATHERECTOMY SYSTEM CONSOLE CATHETER, PERIPHERAL, ATHERECTOMY

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BOSTON SCIENTIFIC CORPORATION JETSTREAM PV ATHERECTOMY SYSTEM CONSOLE CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Device Problems Noise, Audible (3273); Intermittent Loss of Power (4016)
Patient Problem Embolism (1829)
Event Date 03/12/2019
Event Type  Injury  
Event Description
It was reported that the device became entrapped on the guidewire, a loss of rotation occurred and the patient experienced an embolism. Vascular access was gained via the right common femoreal artery to treat the left leg using a non-bsc 7fr braided sheath. The aortic bifurcation had a sharp angle, requiring the braided sheath to provide support to gain access to the contralateral side. A jetstream xc atherectomy catheter and a jetstream console were selected for use in an atherectomy procedure in the heavily calcified distal popliteal artery, just past the knee joint. A non-bsc filter was in place and the jetstream catheter was advanced over a 315cm non-bsc guidewire. Two runs were performed with blades down then with blades up for another run. The catheter was moving up and down the wire initially without issue. The rex function was used every 30 seconds. At no point was the distal tip of the catheter sitting on the wire during operation or while the tip was rotating for longer than a few seconds, as confirmed by the wire loop in the wire guard increasing and decreasing during the operation. As the case progressed, the catheter became more and more difficult to move along the wire. A second proximal lesion in the superficial femoral artery (sfa) was treated with 1 to 2 passed on blades down; however the catheter became impossible to move along the wire. In addition, despite pressing the forward button on the jetstream, the motor on the jetstream console would no longer rotate. There was a small wirrr sound for about a second, but then the jetstream was silent. This occurred at about 10 minutes of jetstream usage time, as indicated on the jetstream console. As a result, the entire system had to be pulled out of the leg and through the sheath as one unit. The patient subsequently had tibial emboli that was treated successfully but resulted in longer procedure time.
 
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Brand NameJETSTREAM PV ATHERECTOMY SYSTEM CONSOLE
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
EP TECHNOLOGIES, INC.
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8440034
MDR Text Key139446196
Report Number2134265-2019-02749
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeAS
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 03/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received03/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/21/2019 Patient Sequence Number: 1
Treatment
FILTER: DISTAL NAV6 EMBOSHIELD; GUIDEWIRE: 315CM ABBOTT BAREWIRE; SHEATH: 7FR ARROW BRAIDED
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