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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 Fluid/Blood Leak (1250); Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/26/2019
Event Type  malfunction  
Event Description
It was reported that the device was not running full speed.A 2.1mm jetstream xc catheter was selected for an atherectomy procedure.During the procedure, the control pod was dripping excessively and indicated the blades were not spinning at full speed.One pass was made.Imaging was completed and it was decided to complete the procedure via ballooning.No patient complications were reported and the patient had a good outcome.
 
Event Description
It was reported that the device was not running full speed.A 2.1mm jetstream xc catheter was selected for an atherectomy procedure.During the procedure, the control pod was dripping excessively and indicated the blades were not spinning at full speed.One pass was made.Imaging was completed and it was decided to complete the procedure via ballooning.No patient complications were reported and the patient had a good outcome.
 
Manufacturer Narrative
Device evaluated by manufacturer.Analysis consisted of visual examination of the device which showed no damage on the catheter shaft.The functionality of the device was checked and the device primed as designed.The device activated and was run for a period of 3 minutes in the blades up and down modes.There were no issues with running the device.No errors were noticed on the console.
 
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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 Key9415872
MDR Text Key169354516
Report Number2134265-2019-14970
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 12/13/2019
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 Model Number45007
Device Catalogue Number45007
Device Lot Number0023651520
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2019
Initial Date Manufacturer Received 11/26/2019
Initial Date FDA Received12/05/2019
Supplement Dates Manufacturer Received12/11/2019
Supplement Dates FDA Received12/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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