Model Number FA-77375-16 |
Device Problem
Flaked (1246)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/28/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned for evaluation; without return of the device, no definitive conclusions can be drawn regarding the clinical observation.Attempts were made to obtain additional information, however, no further information was provided.
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Event Description
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Medtronic received information that physician didn䔠use the device because when it was removed from the package the "teflon" was falling off the "wire guide".It was reported that during flow-diversion treatment the device was introduced into the microcatheter and the "teflon" coverage was falling off the "wire guide." no patient injury was reported.
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Manufacturer Narrative
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Related to correction/recall number: 2029214-10/7/16-001-r.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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