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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION JETSTREAM XC CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45007
Device Problems Mechanical Problem (1384); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/20/2020
Event Type  malfunction  
Event Description
It was reported that there was a loss of rotation. A 2. 4mm jetstream xc was selected for an atherectomy procedure in the right superficial femoral artery. The catheter was prepped and set up. While in the body during the first pass, the sound changed and the catheter stopped spinning in blades down mode. The catheter was removed from the body and the procedure was completed with a second device. There were no patient complications and the patient was stable post procedure.
 
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Brand NameJETSTREAM XC
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 Key10809454
MDR Text Key215300295
Report Number2134265-2020-15527
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/08/2021
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0024570151
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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