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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 10/25/2019
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that there was a loss of aspiration.A 2.1mm jetstream xc catheter was selected for use for an atherectomy procedure in the left superficial femoral artery (sfa).During the beginning of the procedure, aspiration was lost.The device was removed and the procedure was successfully completed with another 2.1mm jetstream xc catheter.There were no patient complications reported.The patient's status was fine.
 
Event Description
It was reported that there was a loss of aspiration.A 2.1mm jetstream xc catheter was selected for use for an atherectomy procedure in the left superficial femoral artery (sfa).During the beginning of the procedure, aspiration was lost.The device was removed and the procedure was successfully completed with another 2.1mm jetstream xc catheter.There were no patient complications reported.The patient's status was fine.
 
Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by manufacturer: returned product consisted of a jetstream xc-2.1mm atherectomy catheter.The device was visually examined and it was noticed that there was kink located 49.5cm from the tip.Functional analysis was done by completing the setup procedure and performing aspiration testing of the device.Test results showed that this device did not perform as designed per the test procedure specification withdrawing 1ml of fluid in the 1 minute time frame.Inspection of the remainder of the device, revealed no damage or irregularities.
 
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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 Key9316464
MDR Text Key173448797
Report Number2134265-2019-13707
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 12/05/2019
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 Number0024159043
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2019
Initial Date Manufacturer Received 10/25/2019
Initial Date FDA Received11/13/2019
Supplement Dates Manufacturer Received12/04/2019
Supplement Dates FDA Received12/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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