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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ZELANTEDVT; CATHETER, EMBOLECTOMY
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BOSTON SCIENTIFIC CORPORATION ANGIOJET ZELANTEDVT; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 45027
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/01/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
 
Event Description
It was reported that an error message occurred.An angiojet xvg was used for a thrombectomy procedure.During the procedure, it was noted that the an error message was displayed.No patient complications were reported.
 
Manufacturer Narrative
B3: date of event - it was further reported that event date was on (b)(6) 2020.Updated: b5 - describe event or problem.
 
Event Description
It was reported that an error message occurred.An angiojet xvg was used for a thrombectomy procedure.During the procedure, it was noted that the an error message was displayed.No patient complications were reported.It was further reported that correct device should have been an angiojet zelantedvt, not the initially reported angiojet xvg.An error message was displayed indicating to replace the thrombectomy set.The procedure was completed with a non-bsc device.
 
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Brand Name
ANGIOJET ZELANTEDVT
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10417005
MDR Text Key203305014
Report Number2134265-2020-11024
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
PMA/PMN Number
K151313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/07/2021
Device Model Number45027
Device Catalogue Number45027
Device Lot Number0023542979
Was Device Available for Evaluation? No
Date Manufacturer Received08/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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