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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
Medical Device Problem Code Suction Problem (2170)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/01/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
 
Event or Problem Description
It was reported that loss of aspiration occurred.An angiojet zelantedvt catheter was used for a thrombectomy procedure.During the procedure, it was noted that the catheter stopped aspirating.The procedure was completed with another of the same device.No patient complications were reported.
 
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Brand Name
ANGIOJET ZELANTEDVT
Common Device Name
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11260845
Report Number2134265-2021-01001
Device Sequence Number714912
Product Code KRA
UDI-Device Identifier08714729904724
UDI-Public08714729904724
Combination Product (Y/N)N
Initial Reporter StateAR
Initial Reporter CountryUS
PMA/510(K) Number
K151313
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 02/01/2021
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
Operator of Device Health Professional
Device Expiration Date10/06/2022
Device Model Number45027
Device Catalogue Number45027
Device Lot Number0026254958
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/15/2021
Initial Report FDA Received Date02/01/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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