MAUDE Adverse Event Report: ACCLARENT, INC. ACCLARENT BALLOON INFLATION DEVICE; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number	BID30
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during a hybrid balloon sinuplasty procedure (bsp), when the acclarent balloon inflation device (bid30 / 96375267) was removed from its packaging, a white substance was noticed on the handle of the device.The reporter stated that ¿the white substance may have been paper from the label rubbing off.¿ the acclarent balloon inflation device was replaced with another from the same lot (96375267), but the same white substance was noticed on the handle.The device was replaced a third time, and the third device had no white substance on it.The procedure was resumed.There was no negative patient impact reported.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, sex, gender, weight, race, and ethnicity were not provided.Section h.3: the device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (96375267) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no internal actions related to device manufacture or inspection.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.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.
Additional 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 20-jan-2025.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile acclarent balloon inflation device was received contained in the decontamination pouch.Visual inspection was performed.White spots were noted along the entire length of the syringe barrel.The device was sent for fourier transform infrared spectroscopy (ftir) investigation and the white stains were analyzed.The ftir spectra suggest the possible presence of inorganic salts (sodium, calcium), polymeric residues, or organic compounds.As a hypothesis, the residues may have resulted from contact with medical solutions (such as contrast media or saline solution), biological fluids, or the effects of cleaning and sterilization process.A manufacturing record evaluation was performed and no non-conformances related to the complaint was found during the review.The issue reported regarding white substance on the handle is confirmed.The device was removed from its original package and handled in an unknown manner, there were no signs of damage to the device prior to use; therefore, the issue reported cannot be traced to the assembly of the device.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device since, as part of acclarent quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damages from leaving the facility.It should be noted that product failure is multifactorial.The instructions for use (ifu) warns the following: do not use a device where the integrity of the sterile packaging has been compromised or if the device appears damaged.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.Updated sections: b.4, g.3, g.6.H.2, h.3, h.6, and h.11.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: ACCLARENT BALLOON INFLATION DEVICE
• Common Device Name: 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 ; 303552-6892
• MDR Report Key: 21022653
• Report Number: 3005172759-2024-00097
• Device Sequence Number: 13056556
• Product Code: LRC
• UDI-Device Identifier: 10705031063570
• UDI-Public: (01)10705031063570(11)240630(17)270630(10)96375267
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K052198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: BID30
• Device Lot Number: 96375267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 01/20/2025; 02/11/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/20/2025; 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown