MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT - 1PK

Model Number RSP0616MFSNZ

Device Problem Incorrect Interpretation of Signal (1543)

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

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (210525a-pc) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 hybrid functional endoscopic sinus surgery (fess) procedure that was aimed to target all six sinuses; it was reported that accuracy of the 6mm x 16mm relieva spinplus navigation balloon sinuplasty system (rsp0616mfsnz / 210525a-pc) was ¿off¿ on the trudi navigation system.The positioning was verified and ¿everything was green.¿ the probe accuracy was reported to ¿looked good.¿ the spinplus navigation balloon was replaced, but there was no resolution.The procedure was continued and completed with a replacement product.The reported issue occurred after the balloon had been inflated twice.The guide / balloon was not flushed prior to use.The balloon was appropriately folded prior to insertion.There was no report of any patient adverse event or complication.Additional information was received on 20 july 2021.The information indicated that the position was verified internally using anatomical landmarks and externally using along the bridge of the nose.All status symbols on the workstation indicated properly connected instruments and properly placed within the trudi zone without metal interference.There were no error messages on the trudi nav monitor.The status was green.The device was plugged in after registration.The inconsistency was detected by the surgeon while using it during the procedure when comparing it to internal landmarks.The accuracy was not within 2mm.The registration was repeated after inaccuracy was detected.The computed tomography (ct) was the primary image.The ct had over 300 slices.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during an in-office primary hybrid functional endoscopic sinus surgery (fess) procedure that was aimed to target all six sinuses; it was reported that accuracy of the 6mm x 16mm relieva spinplus navigation balloon sinuplasty system ((b)(6)) was ¿off¿ on the trudi navigation system.The positioning was verified and ¿everything was green.¿ the probe accuracy was reported to ¿looked good.¿ the spinplus navigation balloon was replaced, but there was no resolution.The procedure was continued and completed with a replacement product.The reported issue occurred after the balloon had been inflated twice.The guide / balloon was not flushed prior to use.The balloon was appropriately folded prior to insertion.There was no report of any patient adverse event or complication.Additional information was received on 20 july 2021.The information indicated that the position was verified internally using anatomical landmarks and externally using along the bridge of the nose.All status symbols on the workstation indicated properly connected instruments and properly placed within the trudi zone without metal interference.There were no error messages on the trudi nav monitor.The status was green.The device was plugged in after registration.The inconsistency was detected by the surgeon while using it during the procedure when comparing it to internal landmarks.The accuracy was not within 2mm.The registration was repeated after inaccuracy was detected.The computed tomography (ct) was the primary image.The ct had over 300 slices.The complaint device was returned and received for evaluation and analysis.The visual inspection finding is documented below.Investigation summary: the non-sterile 6mm x 16mm relieva spinplus navigation balloon sinuplasty system was received.Visual inspection was performed.It was observed that the spinplus navigation balloon had a kink at the distal tip of the navigation wire.In addition, the connector was found cut off from the device.Functional evaluation was precluded due to the observations made during the visual inspection.The distal tip of the navigation wire is kinked and the connector was cut off.The observed kinked area at the distal tip of the navigation wire may be related to the reported accuracy issue of the device being ¿off¿ on the trudi navigation system during the procedure.However, this cannot be conclusively determined.A review of manufacturing documentation associated with this lot (210525a-pc) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of acclarent quality process all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.However, instructions for use (ifu) states that sinus navigation guidewire is a precision instrument and must be handled with care.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 10 august 2021.A supplemental 3500a report will be submitted once the product investigation has been completed.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.

• Brand Name: RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT - 1PK
• Type of Device: RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• MDR Report Key: 12277822
• MDR Text Key: 265169787
• Report Number: 3005172759-2021-00009
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 20705031245430
• UDI-Public: 20705031245430
• 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,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2023
• Device Model Number: RSP0616MFSNZ
• Device Catalogue Number: RSP0616MFSNZ
• Device Lot Number: 210525A-PC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1