• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION JETSTREAM XC ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45007
Device Problems Entrapment of Device (1212); Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/12/2020
Event Type  malfunction  
Event Description
It was reported that there was a loss of rotation and the device became stuck on the guidewire. A 2. 4mm jetstream xc atherectomy catheter was selected to treat a long 30cm instent restenosis within the superficial femoral artery (sfa). During the procedure near the end of the atherectomy portion of the procedure, the device stopped rotating. Retraction mode was also unable to be used. The device became stuck on the thruway guidewire. The jetstream device and thruway guidewire were removed from the patient together. Ballooning was performed to complete the procedure. There were no patient complications and the procedure was successfully completed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10897563
MDR Text Key219184766
Report Number2134265-2020-16380
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeDA
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 12/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0026050229
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 Received12/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/21/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

-
-