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

Catalog Number RSP0616MFS

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2018

Event Type  malfunction  

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 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
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine 92618
• Manufacturer (Section G): ACCLARENT, INC.; 33 technology drive; irvine 92618
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine 92618 ; 949789-383
• MDR Report Key: 7267185
• MDR Text Key: 100128774
• Report Number: 3005172759-2018-00105
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10705031232389
• UDI-Public: 10705031232389
• Combination Product (y/n): N
• PMA/PMN Number: K143541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1