Catalog Number 1007710 |
Device Problems
Difficult To Position (1467); Difficult to Remove (1528); Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/04/2017 |
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 was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The supera referenced is being filed under a separate medwatch report number.
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Event Description
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It was reported that the procedure was to treat a moderately calcified superficial femoral artery.During deployment of the 5.5 x 150 mm supera self-expanding stent, it was noted that the deployment felt different.The stent was fully deployed but when trying to advance the steel core guide wire, it froze in the supera delivery system and the tip separated.The guide wire was wrapped around the delivery system when removed from the anatomy and the tip was on the guide wire.The procedure was completed at this time.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.
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Manufacturer Narrative
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Internal file number - (b)(4).Evaluation summary: visual and dimensional inspections were performed on the returned device.The reported difficulties could not be confirmed as it was based on operational circumstances of the procedure.The investigation determined the reported difficulties to be related to the patient anatomical conditions.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.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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