Model Number 1873 |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: used the first date of the month of the aware date as no event date was provided.
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Event Description
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It was reported that stent damage occurred.A 4.50 x 24 synergy drug-eluting stent and a 6f guidezilla ii guide extension catheter were selected for use.During procedure, it was noted that the stent clung to the junction zone of the guidezilla and the stent struts came out.The procedure time was lengthened but no clinical consequence were observed.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.The hypotube, collar, distal shaft and tip was microscopically and visually inspected.Visual inspection revealed multiple minor flat spots along the distal shaft.Microscopic inspection revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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It was reported that stent damage occurred.A 4.50 x 24 synergy drug-eluting stent and a 6f guidezilla ii guide extension catheter were selected for use.During procedure, it was noted that the stent clung to the junction zone of the guidezilla and the stent struts came out.The procedure time was lengthened but no clinical consequence were observed.
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Search Alerts/Recalls
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