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

Catalog Number RSP0616MFS

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2018

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.[conclusion]: the healthcare professional reported that during the primary functional endoscopic sinus surgery (fess) procedure on (b)(6) 2018, the clear plastic portion on frontal guide catheter that is part of the relieva spinplus kit, 3 guides, 6mm (rsp0616mfs / 180312a-pc) became cracked / broken during the treatment of the left frontal sinus.Per the acclarent sales representative, the patient¿s anatomy was challenging to maneuver around; the plastic portion on the guide catheter broke but did not become separated from the guide catheter shaft.The spinplus balloon catheter had been inflated two to three times before the issue with the frontal guide catheter occurred.The physician had performed a septoplasty before the attempt to treat the left frontal sinus.The spinplus balloon catheter was replaced and the procedure was resumed and subsequently completed.There was no report of any patient injury or adverse event associated with the reported issue.The device was returned for analysis.The investigational finding is documented below.The lot history record (lhr) was reviewed for lot 180312a-pc.No anomalies were found related to this complaint.In addition, the lhr review verifies that the device was manufactured in accordance with documented specification and procedures.Acclarent received the returned package on 10/16/2018, which included the relieva spinplus kit and the f-70 frontal guide catheter.Before undergoing decontamination, the returned device was visually inspected.It was noted that the guide catheter has a broken plastic tip; the area of damage is located at the clear plastic portion on the guide catheter.The broken piece is still attached to the guide catheter; no piece became separated.The returned device underwent decontamination.After decontamination, the spinplus device was tested; there was no advancing / retracting issues noted with the guide wire or the balloon catheter.The customer reported issue related to the guide catheter being broken was confirmed.With the information provided in the complaint and the returned device for investigation, the issue reported that the frontal guide catheter broke during the procedure but did not become separated from the shaft of the guide catheter was confirmed.Based on the lot history record (lhr) review, there is no indication that the event is related to the device manufacturing process.The exact cause of the failure could not be conclusively determined; however, it was reported that the patient¿s anatomy was challenging to maneuver around.This could likely have caused the clear plastic portion of the guide catheter to break while the physician was trying to maneuver around the patient¿s anatomy.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 Description

The healthcare professional reported that during the primary functional endoscopic sinus surgery (fess) procedure on (b)(6) 2018, the clear plastic portion on frontal guide catheter that is part of the relieva spinplus kit, 3 guides, 6mm (rsp0616mfs / 180312a-pc) became cracked / broken during the treatment of the left frontal sinus.Per the acclarent sales representative, the patient¿s anatomy was challenging to maneuver around; the plastic portion on the guide catheter broke but did not become separated from the guide catheter shaft.The spinplus balloon catheter had been inflated two to three times before the issue with the frontal guide catheter occurred.The physician had performed a septoplasty before the attempt to treat the left frontal sinus.The spinplus balloon catheter was replaced and the procedure was resumed and subsequently completed.There was no report of any patient injury or adverse event associated with 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 CA 92618
• Manufacturer (Section G): ACCLARENT, INC.; 33 technology drive; irvine 92618
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine 92618 ; 949789-868
• MDR Report Key: 7992782
• MDR Text Key: 126243075
• Report Number: 3005172759-2018-00114
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10705031232389
• UDI-Public: 10705031232389
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2020
• Device Catalogue Number: RSP0616MFS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2018
• 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