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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 Problem Positioning Failure (1158)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/03/2020
Event Type  malfunction  
Event Description
It was reported that stent failure to deploy occurred and the procedure was cancelled.The target lesion was located in the internal carotid artery.The patient was sedated and after the puncture needle was inserted about 4cm, it was noticed that there was a bright red blood squirting out in the femoral artery.An 8f catheter sheath was inserted and an 8f guide catheter was advanced to the ostial of the left carotid artery.Subsequently, a 8.0-29 carotid wallstent monorail stent was advanced along the 0.014 micro guidewire under the road diagram.However, the stent failed to deploy even after several attempts due to vessel tortuosity and stent obstruction in front.The procedure was not completed due to this event and there were no patient complications nor injuries reported and the patient was stable.
 
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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 Key10295141
MDR Text Key199471811
Report Number2134265-2020-09495
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial
Report Date 07/20/2020
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 Date06/11/2023
Device Model Number26605
Device Catalogue Number26605
Device Lot Number0024915422
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/08/2020
Initial Date FDA Received07/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/11/2019
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 Age72 YR
Patient Weight55
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