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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 Problem Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/22/2021
Event Type  malfunction  
Manufacturer Narrative
Device eval by mfr: the jetstream device xc 2.4 was received by boston scientific for analysis.Visual examination showed multiple kinks located 1cm, 15cm and 16cm from the tip.There was blood in the aspiration line.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 gear slides off the shaft and does not contact the motor gear, rotation of the tip would stop.The gear was removed and inspected.Adhesive was present on the gear as designed.
 
Event Description
Reportable based on device analysis completed 28oct2021.It was reported that the device stopped working.A 2.4mm jetstream catheter was selected for use in an atherectomy procedure.During the procedure, the device stopped working and could not be reactivated.A new jetstream was used to complete the procedure.There were no patient complications.However, device analysis revealed the motor was functional but the blades would not rotate.
 
Event Description
Reportable based on device analysis completed 28oct2021.It was reported that the device stopped working.A 2.4mm jetstream catheter was selected for use in an atherectomy procedure.During the procedure, the device stopped working and could not be reactivated.A new jetstream was used to complete the procedure.There were no patient complications.However, device analysis revealed the motor was functional but the blades would not rotate.
 
Manufacturer Narrative
H6: evaluation conclusion code: updated to quality control deficiency.Device eval by mfr: the jetstream device xc 2.4 was received by boston scientific for analysis.Visual examination showed multiple kinks located 1cm, 15cm and 16cm from the tip.There was blood in the aspiration line.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 gear slides off the shaft and does not contact the motor gear, rotation of the tip would stop.The gear was removed and inspected.Adhesive was present on the gear as designed.
 
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Brand Name
JETSTREAM XC
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 Key12797304
MDR Text Key280943828
Report Number2134265-2021-13915
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729889922
UDI-Public08714729889922
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/23/2023
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0027719602
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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