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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 Entrapment of Device (1212)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/27/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that catheter stuck on guidewire occurred.An angiojet zelantedvt catheter was used for a thrombectomy procedure.During the procedure, it was noted that the catheter froze on a non-bsc hydrophilic wire and was unable to separate.The devices and the sheath were simply removed from the patient's body as one unit.The procedure was completed with a different device.No patient complications or injuries 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 Key11308232
Report Number2134265-2021-01479
Device Sequence Number3384365
Product Code KRA
UDI-Device Identifier08714729904724
UDI-Public08714729904724
Combination Product (Y/N)N
Initial Reporter StateNY
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 Physician
Type of Report Initial
Report Date (Section B) 02/10/2021
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 Date11/18/2022
Device Model Number45027
Device Catalogue Number45027
Device Lot Number0026440700
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/28/2021
Initial Report FDA Received Date02/10/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
TERUMO STIFF GLIDE WIRE
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