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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 11/15/2018
Event Type  malfunction  
Event Description
It was reported a loss of aspiration occurred during use. A 2. 1mm jetstream xc catheter was selected for an atherectomy procedure in the superficial femoral artery (sfa). The first pass was made successful with the device. An attempt to make a second pass with the device was made; however aspiration quit working. Another of the same device was used to complete the procedure. There were no patient complications and the patient's status is fine.
 
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Brand NameJETSTREAM XC
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
cork business technology park
model farm road
cork
EI
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8133217
MDR Text Key129381388
Report Number2134265-2018-63534
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/06/2019
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0021574414
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/05/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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