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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 Positioning Failure (1158)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/18/2020
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr.: the device was received with the stent in the correct place on the delivery system.The stent could not be fully deployed due to a severe kink and complete break in the outer shaft of the device.A visual and tactile inspection identified a complete break of the outer shaft located approximately at the guidewire port.A severe kink on the inner shaft was also identified at the same location.This type of damage is consistent with excessive force being applied to the device.A visual and microscopic examination identified no issues with the tip of the device.No other issues were identified during the product analysis.
 
Event Description
Reportable based on device analysis completed on 23jul2020.It was reported that stent deployment failure occurred.A 10x31,5.9f,135cm carotid wallstent was advanced for treatment but failed to deploy.The device was removed and the procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed shaft detached/separated.
 
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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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10356206
MDR Text Key201377333
Report Number2134265-2020-10334
Device Sequence Number1
Product Code NIM
UDI-Device Identifier08714729781127
UDI-Public08714729781127
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P050019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 08/03/2020
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 Expiration Date03/05/2022
Device Model Number26665
Device Catalogue Number26665
Device Lot Number0022600937
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/23/2020
Initial Date FDA Received08/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/04/2018
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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