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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM XC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION JETSTREAM XC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45007
Device Problems Failure to Prime (1492); Device Displays Incorrect Message (2591)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/15/2021
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: the jetstream device xc-2.4 was received by boston scientific for analysis.The shaft and the remainder of the device were inspected for damage.Visual examination showed no shaft damage.The functionality of the device was checked by setting up the product per the instructions for use (ifu).The device was primed and activated.The blades spun as designed for a period of 2 minutes in the blades down mode with no issues.The device then entered into the blades up mode and ran for a period of 30 seconds and the blades stopped spinning.The motor on the device was heard, but the blades were not spinning.The device's pod was opened to inspect for damage.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.Device analysis determined the condition of the returned device was not consistent with the reported information of priming and error issues.The complaint about bubble errors was not confirmed; however, blades not spinning due to the gear sliding off the shaft was revealed.
 
Event Description
Reportable based on the product analysis completed on november 29, 2021.It was reported during a rotational atherectomy procedure treating a femoral artery occlusion, a 2.4mm jetstream xc catheter was selected.The device was primed several times unsuccessfully due to bubbles in the system.The device was exchanged and the procedure was completed.Patient was reported stable.However, the returned product analysis revealed that the pinion gear had slipped off the drive shaft.
 
Event Description
Reportable based on the product analysis completed on november 29, 2021.It was reported during a rotational atherectomy procedure treating a femoral artery occlusion, a 2.4mm jetstream xc catheter was selected.The device was primed several times unsuccessfully do to bubbles in the system.The device was exchanged and the procedure was completed.Patient was reported stable.However, the returned product analysis revealed that the pinion gear had slipped off the drive shaft.Device evaluated by mfr: the jetstream device xc-2.4 was received by boston scientific for analysis.The shaft and the remainder of the device were inspected for damage.Visual examination showed no shaft damage.The functionality of the device was checked by setting up the product per the instructions for use (ifu).The device was primed and activated.The blades spun as designed for a period of 2 minutes in the blades down mode with no issues.The device then entered into the blades up mode and ran for a period of 30 seconds and the blades stopped spinning.The motor on the device was heard, but the blades were not spinning.The device's pod was opened to inspect for damage.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.Device analysis determined the condition of the returned device was not consistent with the reported information of priming and error issues.The complaint about bubble errors was not confirmed; however, blades not spinning due to the gear sliding off the shaft was revealed.
 
Manufacturer Narrative
Device evaluated by mfr: the jetstream xc-2.4 device was received by boston scientific for analysis.The shaft and the remainder of the device were inspected for damage.Visual examination showed no shaft damage.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 spin.The device was run for a period of 2 minutes in the blades down mode with no issues.The device was entered into the blades up mode and ran for a period of 30 seconds until the blades stopped spinning.The motor on the device was heard, but the blades were not spinning.The device control pod was opened to inspect for damage.It was observed the pinion gear moved along 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 will stop.Presence of adhesive on the pinion gear was verified.Device analysis determined the condition of the returned device was not consistent with the reported information of bubble error and priming difficulties.
 
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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
cork IRELA ND
EI   IRELAND
Manufacturer Contact
jay johnson johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12957868
MDR Text Key281990626
Report Number2134265-2021-15386
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Number0027121155
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/29/2021
Initial Date FDA Received12/07/2021
Supplement Dates Manufacturer Received01/20/2022
Supplement Dates FDA Received02/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age74 YR
Patient Weight74 KG
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