MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number RSP0616MFSN

Device Problem Incorrect Interpretation of Signal (1543)

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

Event Date 04/01/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint #
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> (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.D.2b: procode is lrc / pgw.D.4: the product lot number was not available / not reported.The expiration date of the device is not known.H.4: the device manufacture date is not known as the device lot number is not available / not reported.The device was discarded; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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 report is being submitted pursuant to the provisions of 21 cfr, part 4.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.

Event Description

The healthcare professional reported that during a primary hybrid functional endoscopic sinus surgery (fess) procedure, the spin plus nav balloon (rsp0616mfsn, lot unknown) was being displayed inappropriately on the trudi system version 2.3.2.3 (400089).The caller noted that the accuracy and location of the balloon was not displayed properly.To troubleshoot, the cable was reseated without resolution.The dongle was exchanged without resolution.The balloon was exchanged, and the issue resolved.The case continued.There was no allegation that a death or serious injury occurred due to the use of the product.There was no report of the patient requiring medical intervention as a result of the alleged product issue.Additional event information was received on 03-apr-2024 indicating that there was no movement with the patient tracker or the patient tracker cable under tension in relation to this event.No more than one ct scan was attempted to be used with one device.The ct image used as the primary image.There was no ferromagnetic material placed within the trudi zone.The emitter pad nor was patient moved.When the accuracy issue was observed, the color on the bar was ¿green¿ on the trudi system monitor.There was no error message on the trudi nav monitor for this device.The device was plugged after registration.The inaccuracy was determined ¿accuracy off¿.The inaccuracy was not within 2 mm.

• Brand Name: RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• 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 ; 3035526892
• MDR Report Key: 19180136
• MDR Text Key: 341239337
• Report Number: 3005172759-2024-00036
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2024

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 Catalogue Number: RSP0616MFSN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/25/2024
• 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