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

Catalog Number RSP0616MFSNZ

Device Problem Material Separation (1562)

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

Event Date 12/22/2023

Event Type  malfunction  

Event Description

The healthcare professional reported that during a primary hybrid functional endoscopic sinus surgery (fess) procedure, the balloon of a relieva spinplus nav balloon sinuplasty system, 6x16mm, 3 guide kit - 1pk (rsp0616mfsnz, 3323111) came off the catheter tip when it was outside the nasal passage/sinus.Little procedural delay was noticed as they only had to open a new balloon.There was no patient injury.Non acclarent devices were used.Other acclarent device(s) functioned as expected.No medical intervention was given as a result the alleged product issue.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section h3 - 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.The manufacturing date and expiration of the lot involved is not available at time of reporting.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 company is seeking this information through the event investigation.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.

Manufacturer Narrative

Product complaint # (b)(4).A non-sterile relieva spinplus nav 6x16mm was received and contained in a decontamination bag.Upon arrival, visual inspection was performed, and it was noticed that the balloon component was detached from the shaft and not returned with the device.Under magnification, residues of plastic were observed on the balloon proximal bond, where the balloon had been previously adhered to the balloon catheter.The manufacturing record evaluation (mre) cannot be performed due to the lot number was not provided.The complaint was confirmed since the balloon catheter was no longer attached to the balloon catheter.With the amount of information available, a root cause for the failure encountered cannot be determined; therefore, procedural factors may have contributed to the issue reported.It should be noted that product failure could be caused by multiple factors.However, instructions for use (ifu) states the following warning/recommendation: never advance or retract the relieva® spin sinus guide catheter tip, or sinus balloon catheter against unknown resistance, as this could cause tissue trauma or device damage.Do not try to move the sinus guide catheter tip or sinus balloon catheter while the sinus balloon is inflated, as this could cause tissue trauma or device damage.To prevent damage to the sinus balloon catheter, it is recommended that the sinus balloon be retracted entirely into the sinus guide catheter tip before removal from the nasal cavity.If excessive force is encountered during sinus balloon retraction into the sinus guide catheter tip, use a second hand to completely retract the sinus balloon into the guide tip before attempting to remove it from the nasal cavity.As part of acclarent¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Since there is no evidence to suggest the failure encountered during the analysis was related to a manufacturing or design issue, no capa activity is required.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint # (b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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
• 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: 18531002
• MDR Text Key: 333157777
• Report Number: 3005172759-2024-00005
• Device Sequence Number: 1
• Product Code: LRC
• 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,Followup,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RSP0616MFSNZ
• Device Lot Number: 3323111-196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1