Catalog Number S-50-040-120-P6 |
Device Problem
Material Separation (1562)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/07/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported during unpacking, the tip of a 5.0 x 40 mm supera peripheral stent delivery system was noted to be separated from the device.Therefore, the device was replaced with another unspecified supera device to successfully complete the procedure.There was no patient involvement.No additional information was provided.
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Manufacturer Narrative
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Internal file number - (b)(4).Evaluation summary: visual inspections were performed on the returned device.The tip detachment was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other similar incidents.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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