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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 Problems Difficult to Remove (1528); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2020
Event Type  malfunction  
Event Description
It was reported that there was difficulty removing the device. A 2. 1mm jetstream xc catheter was selected for an atherectomy procedure. One pass was performed. While removing, there was difficulty using rex mode to get the jetstream off the wire. Eventually the jetstream was removed from the wire and the patient. An attempt was made to go back in with the same device, but the device would not advance on the wire. The procedure was completed with another 2. 1mm jetstream xc catheter. No patient complications were reported.
 
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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 CORPORATION
model farm road
cork
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10719337
MDR Text Key212536885
Report Number2134265-2020-14596
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133023
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 11/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/17/2022
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0025606383
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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