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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 Problem Suction Problem (2170)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2018
Event Type  malfunction  
Event Description
It was reported a loss of aspiration occurred during use.A 2.4mm jetstream xc catheter was selected for a lower extremity angiogram atherectomy procedure.During use inside the patient, the device stopped aspirating.The device was pulled back into an open vessel, rex was performed to try and clear the aspiration port; however it did not work.The device was removed from the patient and rex was performed in priming mode in the saline bowl; however the device still did not clear.Use of the device was discontinued.The procedure was completed successfully with another 2.4mm jetstream catheter.There were no patient complications reported and the patient's status if fine.
 
Manufacturer Narrative
Age at time of event: mid 50's.Device evaluated by mfr: returned product consisted of a jetstream xc-2.4 atherectomy catheter.The device was visually examined for any shaft damage and the functional testing of the device was completed.The device showed no damage.The device was set up per the dfu.The device ran as designed pertaining to the rotation of the device.Functional analysis was done by completing the aspiration testing of the device.The device is tested by using a 100ml beaker of water.The device's tip is submerged in a beaker of fluid and the device is run for a period of 1 minute.The final milliliters of fluid that the beaker shows after the 1minute run time is subtracted from the starting milliliters and the final number is the total that was aspirated.Test results showed that this device did perform as designed.Inspection of the remainder of the device, revealed no irregularities.
 
Event Description
It was reported a loss of aspiration occurred during use.A 2.4mm jetstream xc catheter was selected for a lower extremity angiogram atherectomy procedure.During use inside the patient, the device stopped aspirating.The device was pulled back into an open vessel, rex was performed to try and clear the aspiration port; however it did not work.The device was removed from the patient and rex was performed in priming mode in the saline bowl; however the device still did not clear.Use of the device was discontinued.The procedure was completed successfully with another 2.4mm jetstream catheter.There were no patient complications reported and the patient's status if fine.It was further reported that no error message displayed.No visible defects were noted when the issue occurred.The rex button was used to aspirate and clear the catheter.The lesion was located in the superficial femoral artery.
 
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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 Key8138814
MDR Text Key129577689
Report Number2134265-2018-63595
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729889922
UDI-Public08714729889922
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,health
Type of Report Initial,Followup
Report Date 01/04/2019
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 Expiration Date07/30/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0022588190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2018
Initial Date Manufacturer Received 11/28/2018
Initial Date FDA Received12/06/2018
Supplement Dates Manufacturer Received12/13/2018
Supplement Dates FDA Received01/04/2019
Patient Sequence Number1
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