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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM PV ATHERECTOMY SYSTEM CONSOLE CATHETER, PERIPHERAL, ATHERECTOMY

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BOSTON SCIENTIFIC CORPORATION JETSTREAM PV ATHERECTOMY SYSTEM CONSOLE CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45012
Device Problem Suction Problem (2170)
Patient Problem Embolism (1829)
Event Date 09/19/2018
Event Type  Injury  
Event Description
It was reported that aspiration stopped and embolism occurred. A jetstream pv atherectomy system console and jetstream atherectomy catheter were selected for use. During the procedure, aspiration would suddenly stop. Distal embolization started to occur.
 
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Brand NameJETSTREAM PV ATHERECTOMY SYSTEM CONSOLE
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
EP TECHNOLOGIES, INC.
150 baytech drive
san jose CA 95134
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key7957049
MDR Text Key123416830
Report Number2134265-2018-61743
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082664
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 10/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number45012
Device Catalogue Number45012
Device Lot NumberJET0551
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/11/2018 Patient Sequence Number: 1
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