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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 Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: event date was not reported and was approximated to (b)(6) 2021.
 
Event Description
It was reported that the device was stuck on the wire.An 8x29 carotid wallstent monorail was selected for use in a procedure.During the procedure, a non-boston scientific guidewire became stuck inside the carotid wallstent monorail catheter.No patient complications were reported.
 
Manufacturer Narrative
B3: date of event: event date was not reported and was approximated to (b)(6) 2021.Device eval by manufacturer: a visual examination identified no damage or issues with the returned device.The stent was returned in the correct position on the delivery system.The investigator successfully loaded the device on to a boston scientific 0.014" filterwire without resistance or issues.No issues were identified during the product analysis.
 
Event Description
It was reported that the device was stuck on the wire.An 8x29 carotid wallstent monorail was selected for use in a procedure.During the procedure, a non-boston scientific guidewire became stuck inside the carotid wallstent monorail catheter.No patient complications were 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 CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12620356
MDR Text Key276380715
Report Number2134265-2021-12723
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/14/2021
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 Number0026962239
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/06/2021
Initial Date FDA Received10/12/2021
Supplement Dates Manufacturer Received11/22/2021
Supplement Dates FDA Received12/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MICROVENTION TRAXCESS GUIDEWIRE; MICROVENTION TRAXCESS GUIDEWIRE
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