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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 Leak/Splash (1354); Suction Problem (2170)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/04/2020
Event Type  malfunction  
Event Description
It was reported a loss of aspiration occurred during use.A 2.4mm jetstream xc catheter was selected for an atherectomy procedure in the superficial femoral artery (sfa).During priming, liquid was exiting the bottom of the pod.The device was activated.After four minutes of use, the device stopped aspirating.No error message displayed.The procedure was completed with a different device.There were no patient complications and the patient's status is stable.
 
Manufacturer Narrative
Device eval by manufacturer: 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.Functional analysis was done by completing the setup procedure.The device was analyzed for a leak at the bottom of the pod.No leak was noticed, but fluid was leaking from the guidewire hole.Aspiration testing of the device was completed per the test procedure.The device is tested by using a 100ml beaker of water.The devices tip is submerged in a beaker of fluid and the device is run for a period of 1 minute.Test results showed that this device did not perform per specification withdrawing 1ml of fluid in the 1 minute time frame.Inspection of the remainder of the device, revealed no damage or irregularities.
 
Event Description
It was reported a loss of aspiration occurred during use.A 2.4mm jetstream xc catheter was selected for an atherectomy procedure in the superficial femoral artery (sfa).During priming, liquid was exiting the bottom of the pod.The device was activated.After four minutes of use, the device stopped aspirating.No error message displayed.The procedure was completed with a different device.There were no patient complications and the patient's status is stable.
 
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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 Key9711400
MDR Text Key180125553
Report Number2134265-2020-01536
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 03/19/2020
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 Date10/06/2021
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0024720198
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2020
Initial Date Manufacturer Received 02/04/2020
Initial Date FDA Received02/14/2020
Supplement Dates Manufacturer Received02/29/2020
Supplement Dates FDA Received03/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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