Model Number 26606 |
Device Problems
Difficult to Insert (1316); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter city: (b)(6).
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Event Description
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It was reported that a foreign material was found on the device.The target lesion was located in the internal and common carotid arteries.An 8.0-29 carotid monorail stent was selected for use.However, a resistance was observed when the device was inserted into the y-connector.When the device was pulled back, a metal-like ring attached to the distal tip that appeared like a marker was confirmed.The procedure was then continued and completed with this device as the metal ring could be easily removed from the tip with a finger.No patient complications were reported.
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Manufacturer Narrative
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(e1) initial reporter city: (b)(6) device evaluated by mfr: a carotid device was returned for analysis.The device was returned with the stent deployed from the delivery system.The deployed stent was not returned with the device.A visual and tactile examination identified that the distal end of the t connector hub had come detached and moved along the delivery system.The investigator visually and microscopically examined the foreign material (fm) ring that was received and confirmed that the reported fm from the customer is part of the t connector hub that came detached.No other issues were identified during product analysis.
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Event Description
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It was reported that a foreign material was found on the device.The target lesion was located in the internal and common carotid arteries.An 8.0-29 carotid monorail stent was selected for use.However, a resistance was observed when the device was inserted into the y-connector.When the device was pulled back, a metal-like ring attached to the distal tip that appeared like a marker was confirmed.The procedure was then continued and completed with this device as the metal ring could be easily removed from the tip with a finger.No patient complications were reported.
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Search Alerts/Recalls
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