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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM SC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION JETSTREAM SC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45006
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2021
Event Type  malfunction  
Event Description
It was reported blades stopped spinning.A 1.85mm jetstream sc catheter was being used in an atherectomy treatment procedure.During use, after setup, aspiration worked but the rotation function was not detected.Staff noted they couldn't hear any sound coming from the pod when trying to forward or rex.The only sound heard was the console spinning its moving parts.No resistance was noted with the device.The physician tried to activate it again, pressing different buttons.The device was unplugged and then plugged again on its console, primed, and tried to activate again without success.The physician did another approach to the lesion and the procedure was completed with a coyote balloon with no patient complications.
 
Manufacturer Narrative
Device/media analysis: the jetstream sc-1.85 device was received by boston scientific for analysis.The shaft and the remainder of the device were inspected for damage.Visual examination showed no damage on the catheter shaft.The pod was opened to verify pinion gear to motor gear contact.The pinion gear was contacting the motor gear.The functionality of the device was checked by setting up the product per the instructions for use (ifu).The device primed as designed.There were no issues with running the device.The device activated and was run for a period of 2 minutes.No errors were noticed on the console.The device was set-up multiple times and each time functioned as designed.Inspection of the remainder of the device revealed no damage or irregularities.
 
Event Description
It was reported blades stopped spinning.A 1.85mm jetstream sc catheter was being used in an atherectomy treatment procedure.During use, after setup, aspiration worked but the rotation function was not detected.Staff noted they couldn't hear any sound coming from the pod when trying to forward or rex.The only sound heard was the console spinning its moving parts.No resistance was noted with the device.The physician tried to activate it again, pressing different buttons.The device was unplugged and then plugged again on its console, primed, and tried to activate again without success.The physician did another approach to the lesion and the procedure was completed with a coyote balloon with no patient complications.
 
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Brand Name
JETSTREAM SC 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
cork IRELA ND
EI   IRELAND
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12578256
MDR Text Key274793839
Report Number2134265-2021-12401
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeBR
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
Report Date 02/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/10/2022
Device Model Number45006
Device Catalogue Number45006
Device Lot Number0026327762
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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