Model Number 26605 |
Device Problem
Entrapment of Device (1212)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: event date was not reported and was approximated to (b)(6) 2021.
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Event Description
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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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Manufacturer Narrative
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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.
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Event Description
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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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Search Alerts/Recalls
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