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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 Difficult or Delayed Activation (2577)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2021
Event Type  malfunction  
Manufacturer Narrative
Device eval by mfr: the jetstream device xc 2.1 was received for analysis.The shaft and the remainder of the device was inspected for damage.Visual examination showed a kink located 1cm from the tip.The functionality of the device was checked by setting up the product per the instructions for use.The device primed as designed.The device was activated, and the blades did not spin as designed.The kink on the shaft was straightened and the device started to rotate.The device was run for a period of 4 minutes and 15 seconds when the devices tip stopped spinning.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 onto the shaft and reengaged with the motor gear and the device was run again.The device functioned and the tip was spinning.
 
Event Description
Reportable based on device analysis completed on 17nov2021.It was reported the device lost all activity.A 2.1 jetstream xc catheter was selected to treat peripheral artery disease (pad) in the popliteal and superficial femoral artery (sfa).During use, the jetstream xc catheter stopped all activity.The device was removed from the patient and tested again.However, it could not be re-activated.Another jetstream was used to complete the procedure.There were no patient complications.However, device analysis revealed the blades stopped spinning.
 
Manufacturer Narrative
Device eval by mfr: the jetstream device xc-2.1 was received for analysis.The shaft and the remainder of the device was inspected for damage.Visual examination showed a kink located 1cm from the tip.The functionality of the device was checked by setting up the product per the instructions for use (ifu).The device primed as designed.The device was activated, and the blades did not spin.The kink on the shaft was straightened and the device started to rotate.The device was run for an extended period of 4 minutes and 15 seconds when the devices tip stopped spinning.The devices motor was heard; however, no tip rotation was noticed.The devices control pod was opened to inspect for damage.It was noticed the pinion gear had slipped off the drive shaft and was not in contact with the motor gear.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 onto the shaft and reengaged with the motor gear and the device was run again.The device functioned and the tip was spinning.Device analysis determined the condition of the returned device was consistent with the reported information of an unexpected shut down.
 
Event Description
Reportable based on device analysis completed on 17nov2021.It was reported the device lost all activity.A 2.1 jetstream xc catheter was selected to treat peripheral artery disease (pad) in the popliteal and superficial femoral artery (sfa).During use, the jetstream xc catheter stopped all activity.The device was removed from the patient and tested again.However, it could not be re-activated.Another jetstream was used to complete the procedure.There were no patient complications.However, device analysis revealed the blades stopped spinning.
 
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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 Key12960730
MDR Text Key281918579
Report Number2134265-2021-14760
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729889892
UDI-Public08714729889892
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 02/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/13/2023
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0027121146
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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