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

Model Number RSP0616MFSN

Device Problem Incorrect Interpretation of Signal (1543)

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

Event Date 10/27/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Procode is lrc/pgw.The expiration date of the device is not known as the device lot number is not available / not reported.The name, phone and email address of the initial reporter are not available / reported.The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: the healthcare professional reported that during a primary standard functional endoscopic sinus surgery (fess) procedure with balloon sinuplasty, the following devices were used: a 0° trudi nav suction device (tdns000z / lot#: unknown), a 6mm x 16mm relieva spinplus navigation balloon sinuplasty system (rsp0616mfsn / lot# unknown), and an unknown curve suction device (catalog / lot# unknown) were used and there were accuracy issues intermittently throughout the case on all three devices.The healthcare professional reported that the accuracy issue was off from the start of the procedure.The emitter pad was checked without resolution.The trudi system was restarted by doing a full shutdown, the patient was re-registered, and the registration technique was changed ¿ the accuracy issue was reportedly better, but still off.It was reported that the registration technique was changed because they had originally used a mini computerized axial tomography (cat) scan instead of a full cat scan.All devices were shown green on the trudi system.The procedure was completed without resolution.There was no negative patient impact.Based on complaint information, the device is not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the complaint product available to be returned for analysis, the reported issue in the complaint cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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.This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3005172759-2022-00034, 3005172759-2022-00035, and 3005172759-2022-00036.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by acclarent, or its employees that the report constitutes an admission that the product, acclarent, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 a primary standard functional endoscopic sinus surgery (fess) procedure with balloon sinuplasty, the following devices were used: a 0° trudi nav suction device (tdns000z / lot#: unknown), a 6mm x 16mm relieva spinplus navigation balloon sinuplasty system (rsp0616mfsn / lot# unknown), and an unknown curve suction device (catalog / lot# unknown) were used and there were accuracy issues intermittently throughout the case on all three devices.The healthcare professional reported that the accuracy issue was off from the start of the procedure.The emitter pad was checked without resolution.The trudi system was restarted by doing a full shutdown, the patient was re-registered, and the registration technique was changed ¿ the accuracy issue was reportedly better, but still off.It was reported that the registration technique was changed because they had originally used a mini computerized axial tomography (cat) scan instead of a full cat scan.All devices were shown green on the trudi system.The procedure was completed without resolution.There was no negative patient impact.The devices are reportedly not available to be returned.

• Brand Name: RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer (Section G): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 15837825
• MDR Text Key: 307917664
• Report Number: 3005172759-2022-00035
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10705031241015
• UDI-Public: 10705031241015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RSP0616MFSN
• Device Catalogue Number: RSP0616MFSN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: OLYMPUS SHAVER; TRUDI SUCTION, 0 - 1PK; UNK_REUSABLE INSTRUMENTS