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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 Problems Mechanical Problem (1384); Suction Problem (2170)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2019
Event Type  malfunction  
Event Description
It was reported that the device was not aspirating correctly.A jetstream xc catheter, 2.1mm was selected for a right superficial artery (sfa) atherectomy procedure.During the procedure, it was noted that the device was not aspirating correctly and was very slow.No atherectomy lubricant was used during the procedure.The device was removed from the patient and the procedure was completed with another jetstream device.No patient complications were reported.
 
Manufacturer Narrative
H6: device codes: device code updated from mechanical problem 1384 to suction problem 2170.Device evaluated by manufacturer.The device was visually examined for any shaft damage and the functional testing of the device was completed.The device showed no damage.Functional analysis was done by completing the setup procedure per the directions for use.Aspiration testing of the device was done per the test procedure.Test results showed that this device did not perform as designed per the test procedure specification sheet.Inspection of the remainder of the device, revealed no damage or irregularities.
 
Event Description
It was reported that the device was not aspirating correctly.A jetstream xc catheter, 2.1mm was selected for a right superficial artery (sfa) atherectomy procedure.During the procedure, it was noted that the device was not aspirating correctly and was very slow.No atherectomy lubricant was used during the procedure.The device was removed from the patient and the procedure was completed with another jetstream device.No patient complications were reported.
 
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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
MDR Report Key9426040
MDR Text Key175680825
Report Number2134265-2019-15042
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729889892
UDI-Public08714729889892
Combination Product (y/n)N
PMA/PMN Number
K133023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/14/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0022510039
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Date Manufacturer Received12/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age72 YR
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