Catalog Number NEXHD1552401 |
Device Problem
Aspiration Issue (2883)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/05/2016 |
Event Type
malfunction
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Manufacturer Narrative
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It was indicated that the device will not be returned for evaluation because the device remains implanted; therefore an analysis of the complaint device could not be completed.A review of the manufacturing documentation confirmed that the lot met the specification requirements.The review found no deviations or non-conformances that would have contributed to the reported complaint.Taking into consideration the evaluation conducted and the details of the complaint, this investigation was assigned the most probable root cause of an anticipated procedural complication.A complaint with a most probable root cause classification of an anticipated procedural complication indicates that a device related root cause does not apply and the complaint is due to a known effect of the procedure.
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Event Description
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(b)(4).The nexsite device was placed successfully on (b)(6) 2015.On (b)(6) 2016, lack of arterial limb aspirate was reported.The event was mild in nature and no action was taken with the study device.Cathflo was given as a clotbuster and the event had resolved on the same date.
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Search Alerts/Recalls
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