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 Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2020
Event Type  malfunction  
Event Description
It was reported that the blades stopped spinning.A 2.4mm jetstream xc atherectomy catheter was selected for use in an atherectomy procedure in the superficial femoral artery (sfa).During the procedure, the device ran for 14 minutes 6 seconds without issue until it jammed.The rex, blades down, and blades up buttons were all pressed several times, but the device continued jamming.The device was moved to a different area on the guidewire, but it still did not work.The device was removed, and the procedure was completed with balloon angioplasty.No patient complications were reported.
 
Event Description
It was reported that the blades stopped spinning.A 2.4mm jetstream xc atherectomy catheter was selected for use in an atherectomy procedure in the superficial femoral artery (sfa).During the procedure, the device ran for 14 minutes 6 seconds without issue until it jammed.The rex, blades down, and blades up buttons were all pressed several times, but the device continued jamming.The device was moved to a different area on the guidewire, but it still did not work.The device was removed, and the procedure was completed with balloon angioplasty.No patient complications were reported.It was further reported that the device made a short noise and then went silent and would no longer work.When the treatment buttons were pressed, the device would no longer activate.There was no damage the jetstream or the thruway guidewire used and no error message displayed.The jetstream was removed over the guidewire.
 
Event Description
It was reported that the blades stopped spinning.A 2.4mm jetstream xc atherectomy catheter was selected for use in an atherectomy procedure in the superficial femoral artery (sfa).During the procedure, the device ran for 14 minutes 6 seconds without issue until it jammed.The rex, blades down, and blades up buttons were all pressed several times, but the device continued jamming.The device was moved to a different area on the guidewire, but it still did not work.The device was removed, and the procedure was completed with balloon angioplasty.No patient complications were reported.It was further reported that the device made a short noise and then went silent and would no longer work.When the treatment buttons were pressed, the device would no longer activate.There was no damage the jetstream or the thruway guidewire used and no error message displayed.The jetstream was removed over the guidewire.
 
Manufacturer Narrative
H3: device eval by manufacturer? the 2.4mm jetstream xc atherectomy catheter was returned for analysis.The shaft and the remainder of the device was inspected for damage.Visual examination showed a severe kink located 45cm from the tip.The functionality of the device was checked by setting up the product per the instructions for use (ifu).The device primed.The device was activated, and the blades did not spin.The device was straightened out and catheter shaft manipulated to try and get the blades to function.The blades still would not spin.The pod was opened, and visual analysis was completed and noticed rust on the bearing face which caused it to seize up and not rotate.The rust was cleaned off and the shaft was manually turned to free up the stuck shaft.The pod was reassembled, and the device was tested again by straightening out the catheter shaft and the blades started to spin and function as designed.As there was no evidence of any product quality deficiencies, it was considered likely that the bearing rust was attributable to procedural issues.Device analysis determined the condition of the returned device was consistent with the reported event.
 
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
MDR Report Key11066101
MDR Text Key223443300
Report Number2134265-2020-18350
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/24/2022
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0025252283
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2021
Date Manufacturer Received02/11/2021
Patient Sequence Number1
-
-