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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 11/26/2019
Event Type  malfunction  
Event Description
It was reported that there were aspiration issues.A 2.1mm jetstream xc catheter was selected for a thrombectomy procedure.During the procedure, it was noted that the catheter was defective and the aspiration port was possibly occluded.It is unknown how the procedure was completed.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of a jetstream xc 2.1mm atherectomy catheter.The device was visually examined and it showed no damage.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 6ml 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 that there were aspiration issues.A 2.1mm jetstream xc catheter was selected for a thrombectomy procedure.During the procedure, it was noted that the catheter was defective and the aspiration port was possibly occluded.It is unknown how the procedure was completed.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 Key9439635
MDR Text Key175698476
Report Number2134265-2019-15314
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 12/23/2019
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 Number0024126828
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 Received12/09/2019
Supplement Dates Manufacturer Received12/11/2019
Supplement Dates FDA Received12/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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