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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 Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/24/2021
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 a superficial femoral artery recanalization procedure to treat intra stent occlusion and critical limb ischemia.During the procedure while advancing the device to the lesion in blades down mode, it was noted that the rotation speed slowed down and stopped.Attempts were made to restart rotation in rex mode, but they were unsuccessful.Another 2.4mm jetstream xc atherectomy catheter was used to successfully complete the procedure.No patient complications were reported.
 
Manufacturer Narrative
Device eval by manufacturer: the returned product that was received by boston scientific consisted of a jetstream atherectomy catheter.Visual and microscopic inspection was completed.Visual examination revealed multiple locations of buckling on the sheath.Microscopic examination revealed no additional damages.Functional analysis was performed, and the device primed and ran as designed.This process was repeated multiple times with the same outcome.The device ran for a period of 2 minutes with no issues or errors.Inspection of the remainder of the device presented no damage or irregularities.Product analysis could not confirm the reported event as the device functioned as intended when tested.
 
Event Description
It was reported that the blades stopped spinning.A 2.4mm jetstream xc atherectomy catheter was selected for use in a superficial femoral artery recanalization procedure to treat intra stent occlusion and critical limb ischemia.During the procedure while advancing the device to the lesion in blades down mode, it was noted that the rotation speed slowed down and stopped.Attempts were made to restart rotation in rex mode, but they were unsuccessful.Another 2.4mm jetstream xc atherectomy catheter was used to successfully complete the procedure.No patient complications were reported.
 
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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
MDR Report Key12109423
MDR Text Key259698964
Report Number2134265-2021-08495
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
Report Date 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/30/2023
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0027226433
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2021
Date Manufacturer Received07/14/2021
Patient Sequence Number1
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