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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 Material Deformation (2976); Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Date 06/30/2020
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.An 8.0-21 carotid wallstent was selected for use.Prior to the procedure, it was noticed that the stent was damaged in a curved shape.There was an unusual brown burnt color at the end of the shaft.The device was not used in the patient.There were no patient complications reported.
 
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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 IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10297740
MDR Text Key199549280
Report Number2134265-2020-09461
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P050019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/11/2023
Device Model Number26605
Device Catalogue Number26605
Device Lot Number0025020804
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age77 YR
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