(b)(4).Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.[conclusion]: acclarent was informed on (b)(6) 2018, of an event which occurred during the primary hybrid balloon sinuplasty procedure with turbinate reduction and partial ethmoidectomy on (b)(6) 2018, in which a relieva® flex sinus guide catheter m-90 (gc090rf / 170124c-pc) was used.The healthcare professional reported that the space between the ethmoid bulla and the uncinate process was tight, which made it difficult to access the sinus.The blue tip on the flex guide catheter became detached and fell off after the maxillary sinus was dilated.The tip fell off outside of the patient¿s anatomy; it was discarded.The guide catheter had been used three times before the blue tip became separated.The procedure was continued without the use of the tip; the procedure was completed without further issue and without any patient consequence.Acclarent received the returned relieva flex guide catheter (m-90) on 5/12/2018.The flex guide catheter was visually inspected; the blue tip was observed missing.The reported issue of the blue tip becoming separated from the relieva flex guide catheter was confirmed.Lot history record review was completed and confirmed that lot 170124c-pc met release specifications.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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Acclarent was informed on (b)(6) 2018, of an event which occurred during the primary hybrid balloon sinuplasty procedure with turbinate reduction and partial ethmoidectomy on (b)(6) 2018, in which a relieva® flex sinus guide catheter m-90 (gc090rf / 170124c-pc) was used.The healthcare professional reported that the space between the ethmoid bulla and the uncinate process was tight, which made it difficult to access the sinus.The blue tip on the flex guide catheter became detached and fell off after the maxillary sinus was dilated.The tip fell off outside of the patient¿s anatomy; it was discarded.The guide catheter had been used three times before the blue tip became separated.The procedure was continued without the use of the tip; the procedure was completed without further issue and without any patient consequence.
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