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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID
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BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID Back to Search Results
Model Number 26605
Device Problems Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2022
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.When a 8.0-21 carotid wallstent monorail was removed from the sterile package, a deformation was noticed in the mesh structure and a 0.14 wire did not pass through the lumen.The procedure was completed with another of the same device and there were no patient complications nor injuries reported.
 
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 stent damage occurred.When a 8.0-21 carotid wallstent monorail was removed from the sterile package, a deformation was noticed in the mesh structure and a 0.14 wire did not pass through the lumen.The procedure was completed with another of the same device and there were no patient complications nor injuries reported.
 
Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr: a carotid device was received for analysis.This carotid device is recommended for use with a 0.014 guidewire.The investigator was unable to insert the guidewire on to the device as the shaft of the device was severely kinked.The shaft of the device was severely kinked.The device was returned with the stent fully mounted in the correct location on the device and no issues was noted.
 
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Brand Name
CAROTID WALLSTENT
Type of Device
STENT, CAROTID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16009575
MDR Text Key307938207
Report Number2124215-2022-52396
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/09/2023
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
Device Operator Health Professional
Device Model Number26605
Device Catalogue Number26605
Device Lot Number0027637057
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/05/2022
Initial Date FDA Received12/19/2022
Supplement Dates Manufacturer Received01/19/2023
Supplement Dates FDA Received02/09/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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