Model Number 26605 |
Device Problems
Entrapment of Device (1212); Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.(b)(6).
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Event Description
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It was reported that entrapment on guidewire occurred.The target lesion was located in the internal carotid artery.A 10.0-31 carotid wallstent was selected for use.During the procedure, there was difficulty advancing the stent over the guidewire.The stent became stuck on the wire and both were removed from the patient.The procedure was completed with another of the same guidewire and stent.There were no patient complications and the patient was fine.
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Manufacturer Narrative
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A2: age at time of event: (b)(6).E1: initial reporter phone: (b)(6).Device evaluated by mfr: the device was returned loaded on to the customer guidewire.The device was covered in a red blood like substance.The outer diameter of the guidewire used by the customer was confirmed to measure 0.0135 inch using a snap gauge.During product analysis the customer guidewire was found to be frozen inside the guidewire lumen of the returned device.A microscopic examination identified a blockage at the guidewire port of the device.The customer guidewire was removed.A microscopic examination identified that the polymer coating of the customer guidewire was damaged, peeling and bunched up at more than one location.It is unknown what could have caused this to happen.A new boston scientific 0.014 inch filterwire was successfully inserted through this device with no resistance or issues experienced.A visual and tactile examination identified no issues with the catheter or delivery system that could potentially have contributed to the complaint incident.The device was returned with the stent fully mounted in the correct place on the device.
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Event Description
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It was reported that entrapment on guidewire occurred.The target lesion was located in the internal carotid artery.A 10.0-31 carotid wallstent was selected for use.During the procedure, there was difficulty advancing the stent over the guidewire.The stent became stuck on the wire and both were removed from the patient.The procedure was completed with another of the same guidewire and stent.There were no patient complications and the patient was fine.
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Search Alerts/Recalls
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