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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 26665
Device Problem Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Date 07/10/2019
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.During unpacking of an 8x21, 5f, 135cm carotid wallstent, it was observed that there was a slight bent on the catheter at the portion where the stent was located.The device was never used and the procedure was completed with another of the same device.No patient complications were reported.
 
Event Description
It was reported that stent damage occurred.During unpacking of an 8x21, 5f, 135cm carotid wallstent, it was observed that there was a slight bent on the catheter at the portion where the stent was located.The device was never used and the procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual and tactile examination identified no issues with the catheter or delivery system that could potentially have contributed to the complaint incident.The device was returned with the stent fully mounted in the correct place on the delivery system.No issues were identified during the product analysis.
 
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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
MDR Report Key8841222
MDR Text Key152647556
Report Number2134265-2019-08845
Device Sequence Number1
Product Code NIM
UDI-Device Identifier08714729781189
UDI-Public08714729781189
Combination Product (y/n)N
PMA/PMN Number
P050019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/22/2022
Device Model Number26665
Device Catalogue Number26665
Device Lot Number0023680839
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2019
Date Manufacturer Received08/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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