MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT

Model Number RSP0616MFSN

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).[conclusion]: the healthcare professional reported that during an in-office primary balloon sinuplasty (bsp) procedure on (b)(6) 2021, the 6mm x 16mm relieva spinplus navigation balloon sinuplasty system (rsp0616mfsn / 201124a-pc) was used.The maxillary sinus was being treated when the balloon suddenly burst at 8 atm on the second inflation.The balloon was replaced with another 6mm x 16mm relieva spinplus navigation balloon from the same lot and the replacement also burst suddenly on the first inflation at 8atm.The balloon catheter was replaced for a third time and the replacement balloon was successfully used and the procedure was completed without any patient adverse event or complication.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the complaint device was received.Visual inspection was performed.During the visual analysis, the balloon catheter was observed to be burst; there is evidence that the burst was radial.It was also confirmed during the visual inspection that the observed radial burst did not generate any balloon fragments that became separated from the rest of the device.A review of manufacturing documentation associated with this lot (201124a-pc) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance's related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Balloon catheter burst is a known potential issue associated with the use of this device.The radial burst was not originally reported in the complaint, but it is possible that the condition occurred after the initial burst during the retraction of the device.The exact cause of the observed radial burst as noted during the visual analysis cannot be conclusively determined.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.It should be noted that the product failure is multifactorial.However instructions for use (ifu) states that as the sinus balloon is inflating, monitor the diameter, shape, and position of the sinus balloon under endoscopic visualization, inflate the sinus balloon with sterile saline or sterile water until desired results are achieved and do not exceed 12atm.As part of acclarent quality process all devices are manufactured, inspected, and released to approved specifications.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.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 an in-office primary balloon sinuplasty (bsp) procedure on (b)(6) 2021, the 6mm x 16mm relieva spinplus navigation balloon sinuplasty system (rsp0616mfsn / 201124a-pc) was used.The maxillary sinus was being treated when the balloon suddenly burst at 8 atm on the second inflation.The balloon was replaced with another 6mm x 16mm relieva spinplus navigation balloon from the same lot and the replacement also burst suddenly on the first inflation at 8atm.The balloon catheter was replaced for a third time and the replacement balloon was successfully used and the procedure was completed without any patient adverse event or complication.The complaint devices were returned for evaluation.During the visual inspection of one of the two balloon catheters, there was evidence of a radial burst observed.Based on the product analysis on 19 march 2021, this event has been deemed mdr reportable as a ¿malfunction.¿.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product evaluation and analysis of the complaint device was re-reviewed on 02 june 2021.The reportability of the file was also reassessed.Upon further review of the product investigation, it has been determined that the balloon catheter burst.The originally reported observed radial burst was made in error.With this information, the file no longer meets the medical device reporting criteria as a ¿malfunction.¿ therefore, it has been deemed not reportable.No further reports will be forthcoming.

• Brand Name: RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT
• Type of Device: RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• MDR Report Key: 11555651
• MDR Text Key: 244233941
• Report Number: 3005172759-2021-00003
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10705031241015
• UDI-Public: 10705031241015
• Combination Product (y/n): N
• PMA/PMN Number: K171687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2022
• Device Model Number: RSP0616MFSN
• Device Catalogue Number: RSP0616MFSN
• Device Lot Number: 201124A-PC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 06/02/2021
• Supplement Dates FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYS