Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: the event date was not provided and estimated based on the aware date.
 
Event Description
It was reported that the blades stopped spinning.A 2.4mm jetstream atherectomy catheter was selected for use.The blades stopped spinning during the procedure.However, infusion still functioned.The device was removed from the patient.
 
Manufacturer Narrative
B3 - date of event: the event date was not provided and estimated based on the aware date.
 
Event Description
It was reported that the blades stopped spinning.A 2.4mm jetstream atherectomy catheter was selected for use.The blades stopped spinning during the procedure.However, infusion still functioned.The device was removed from the patient.It was further reported target lesion was located in the common femoral artery.The physician attempted to restart the device several times during the procedure and outside the patient.The procedure was successfully completed with a new device.
 
Event Description
It was reported that the blades stopped spinning.A 2.4mm jetstream atherectomy catheter was selected for use.The blades stopped spinning during the procedure.However, infusion still functioned.The device was removed from the patient.It was further reported target lesion was located in the common femoral artery.The physician attempted to restart the device several times during the procedure and outside the patient.The procedure was successfully completed with a new device.
 
Manufacturer Narrative
B3 - date of event: the event date was not provided and estimated based on the aware date.Device eval by mfr: the jetstream device xc-2.4 was received for analysis.The shaft and the remainder of the device was inspected for damage.Visual examination showed a kink/buckling located 1cm from the tip.The functionality of the device was checked by setting up the product per the ifu.The device primed as designed.The device was activated, and the blades did not spin as designed.The devices motor was heard; however, no tip rotation was noticed.The devices pod was opened to inspect for damage.It was noticed the pinion gear had slipped off the drive shaft.When the pinion gear slides off the shaft and does not contact the motor gear, rotation of the tip would stop.The gear was slid back on the shaft and the device was activated.The device ran and the blades did spin for 3 minutes and the testing was completed.The gear did not slide off after it was slid back on for testing.Device analysis determined the condition of the returned device was consistent with the reported information of blades not spinning.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
JETSTREAM XC ATHERECTOMY CATHETER
Type of Device
CATHETER, 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 Key12550714
MDR Text Key274000356
Report Number2134265-2021-12226
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2023
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0027755155
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ABBOTT BMW GUIDEWIRE; ABBOTT BMW GUIDEWIRE
-
-