MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA FLEX SINUS GUIDE CATHETER, M-90; CANNULA, SINUS

Catalog Number	GC090RF
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 within the middle meatus after the maxillary sinus was dilated.The tip was retrieved and 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.Lot history record review was completed and confirmed that lot 170124c-pc met release specifications.The product was not returned for evaluation; the reported issue of the blue tip becoming separated from the flex guide catheter could not be confirmed.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of causes and possible contributing factors could be made.As such the investigation will be closed.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.
Event or Problem Description
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 within the middle meatus after the maxillary sinus was dilated.The tip was retrieved and 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.

• Brand Name: RELIEVA FLEX SINUS GUIDE CATHETER, M-90
• Common Device Name: CANNULA, SINUS
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine 92618
• MDR Report Key: 7532061
• Report Number: 3005172759-2018-00108
• Device Sequence Number: 184637
• Product Code: LRC
• UDI-Device Identifier: 10705031063457
• UDI-Public: 10705031063457
• Combination Product (Y/N): N
• PMA/510(K) Number: K043445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2019
• Device Catalogue Number: GC090RF
• Device Lot Number: 170124C-PC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1