Model Number 3851 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/26/2020 |
Event Type
malfunction
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Event Description
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It was reported that the device separated.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.Prior procedure, a damage in the mid shaft part was noted; appeared to be separated.The procedure was completed with a different device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was tightly wrapped and had not been subjected to positive pressure.There were no issues noted with the balloon material.All blades were securely bonded and no damage to the blades were noted.The inner lumen damage was noted on the shaft polymer extrusion of this device.The inner lumen was found to be bunched at 8cm distal to the guidewire port.Multiple hypotube kinks were also noted on the device.A visual and microscopic examination found no issue with the marker bands.
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Event Description
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It was reported that the device separated.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.Prior procedure, a damage in the mid shaft part was noted; appeared to be separated.The procedure was completed with a different device.No patient complications were reported.
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Search Alerts/Recalls
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