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Catalog Number RS0616MFS |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/07/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Acclarent received the complaint package on 11/22/2016, which included the following: a.A spin sinuplasty balloon.B.Balloon slider.C.Wire slider.Before decontamination, visual inspection was performed.The following observations were noted: the balloon and the small portion of the shaft were completely separated; these parts did not get sent back.Further inspection of the shaft indicated that there was no evidence of the shaft being cut with a sharp object.The received balloon catheter is not functional.The integrity of the balloon portion of the balloon catheter cannot be determined due to the missing balloon section on the returned device.The customer complaint has been verified.A review of the lot history record for the subject device did not note any anomalies.
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Event Description
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Acclarent was informed on (b)(6) 2016, for an event that occurred on (b)(6) 2016, involving a relieva spin 6x16 sinuplasty system, 3 guide kit (lot# 160406a-pc).The reported issue was that the plastic sheath has been detached.No other information is available.
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Search Alerts/Recalls
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