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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 Mechanical Problem (1384); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2018
Event Type  malfunction  
Event Description
It was reported a loss of rotation occurred during use.A 2.4mm jetstream xc atherectomy catheter was selected for an atherectomy procedure in the highly stenosed and severely calcified superficial femoral artery (sfa) crossover artery with a steep bifurcation.During the procedure, the device was still making noises but stopped drilling.No error message displayed.The procedure was completed with another jetstream catheter.There were no patient complications reported and the patient's status was fine.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a jetstream xc-2.4 atherectomy catheter.The shaft and the remainder of the device were inspected for damage.Visual examination showed a severe kink at the strain relief.The device was set up and functionally tested.The device did not rotate as designed.This damage that was noticed is consistent with drive coil damage and the rotation would not function in this case.
 
Event Description
It was reported a loss of rotation occurred during use.A 2.4mm jetstream xc atherectomy catheter was selected for an atherectomy procedure in the highly stenosed and severely calcified superficial femoral artery (sfa) crossover artery with a steep bifurcation.During the procedure, the device was still making noises but stopped drilling.No error message displayed.The procedure was completed with another jetstream catheter.There were no patient complications reported and the patient's status was fine.
 
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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 Key8165369
MDR Text Key130383068
Report Number2134265-2018-63607
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
PMA/PMN Number
K130637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/11/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0022787703
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2018
Date Manufacturer Received12/18/2018
Patient Sequence Number1
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