ACCLARENT, INC. RELIEVA SPIN PLUS KIT, 3 GUIDES, 6MM, 5PK; INSTRUMENT, ENT MANUAL SURGICAL
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Catalog Number RSP0616MFS |
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 11/16/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The patient identifier is not known.The patient¿s age is not known.The patient's weight is not known.The lot number of the device is not known.The full udi # information is unavailable since the lot number is unavailable.The lot history record review could not be performed as lot number for the acclarent relieva spinplus device was unavailable.If additional information is received regarding this event, a supplemental report will be filed.Manufacturer reference number: (b)(4).
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Event Description
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Acclarent was informed on (b)(6) 2017, for an event that occurred on (b)(6) 2017 involving a relieva spinplus kit, 3 guides, 6mm, 5pk (lot# not available).During the primary hybrid balloon sinuplasty procedure, the physician noticed that the blue tip from the balloon catheter had separated from the balloon and was in the sinus cavity.The blue tip was retrieved with forceps.There was no report of any patient consequence and the procedure was not extended.
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