MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPIN PLUS KIT, 3 GUIDES, 6MM, 5PK; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number	RSP0616MFS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Acclarent received the returned maxillary guide catheter (m-110).Visual inspection was performed prior to decontamination and it was observed that the blue tip on the guide catheter was missing.This observation confirmed the issue reported.A review of the lot history record the subject device (lot# 170712a-pc) did not present any issues during the manufacturing or inspection process that can be related to the reported complaint.Additional information will be submitted within 30 days of receipt.(b)(4).
Event or Problem Description
Acclarent was informed on (b)(4) 2018, of an event that occurred during the primary balloon sinuplasty procedure on the same day, that involved a relieva spinplus® balloon sinuplasty system (rsp0616mfs) from lot#: 170712a-pc.The spinplus balloon catheter was being used to treat the maxillary sinus when the tip of the maxillary guide catheter became detached from the shaft and fell into the middle meatus.There was no injury to the nasal or sinus tissue from the tip detachment; the guide catheter tip was retrieved from the sinus cavity using alligator forceps.There was no report of patient injury or complications as a result of the reported issue.

• Brand Name: RELIEVA SPIN PLUS KIT, 3 GUIDES, 6MM, 5PK
• Common Device Name: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine 92618
• MDR Report Key: 7267185
• Report Number: 3005172759-2018-00105
• Device Sequence Number: 19362055
• Product Code: LRC
• UDI-Device Identifier: 10705031232389
• UDI-Public: 10705031232389
• Combination Product (Y/N): N
• PMA/510(K) Number: K143541
• 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): 01/26/2018

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: 07/12/2019
• Device Catalogue Number: RSP0616MFS
• Device Lot Number: 170712A-PC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Initial Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1