MAUDE Adverse Event Report: ACCLARENT, INC. ACCLARENT PIVOT NAVIGATION BALLOON DILATION SYSTEM; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Model Number PVT0616N

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 05/19/2023

Event Type  Injury  

Event Description

The healthcare professional reported that during an in-office primary balloon sinuplasty (bsp) procedure on (b)(6) 2023, an acclarent pivot navigation balloon dilation system (pvt0616n / lot# unknown) was used.The acclarent device functioned as expected with no intraoperative malfunction or performance issue.The pivot balloon was inflated two times during dilation of the sphenoid sinus.It was reported that dilation of the sphenoid sinus led to the carotid artery ¿blowing.¿ the pivot balloon was left inflated in the sinus to stop the bleeding.The patient was ambu bagged and intubated then the emergency medical technicians (emts) arrived.It was reported that ¿she is doing better now.¿ the patient had not undergone any previous sinus procedure.The physician did not identify any defect in the skull base preoperatively or intraoperatively.In the physician¿s opinion, it was the patient¿s unique anatomy that contributed to the reported adverse event.¿the physician did not blame acclarent.¿ the adverse event resulted in a 3-hour delay in the procedure.The adverse event did result in prolongation of the patient¿s hospitalization, the duration of the patient¿s hospitalization was not provided.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, weight, race, and ethnicity were not provided.Section d.2b: procode is pgw/lrc/pnz.Section d.4: the expiration date of the device is not known as the device lot number is not available / not reported.Section e.1: the initial reporter email address is not available / reported.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.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.The lot number of the device is not known; therefore, manufacturing documentation review not performed.Since the patient experienced a carotid artery blew during the procedure with acclarent devices (acclarent pivot navigation balloon dilation system), which required additional intervention during and after the procedure the event meets us fda reporting criteria under 21 cfr 803 with the classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.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 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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 11-mar-2024.[additional information]: on 11-mar-2024, additional information was received.The information is a legal petition.Per the information received, the petitioner sustained an injury to her carotid artery during a sinus procedure on (b)(6) 2023, that caused her catastrophic neurological injuries.The petitioner has learned that the physician who performed the sinus procedure (a balloon sinuplasty), used a navigation balloon dilation system along with other component parts manufactured by acclarent.It is believed that the specific device used in the procedure was the acclarent pivot navigation balloon dilation system (pvt0616n).On (b)(6) 2023, it is believed that the physician who performed the above-referenced nasal/sinus endoscopy procedure on petitioner at the ear nose & throat institute, utilizing the product in question, manufactured by acclarent.It is believed the acclarent navigation balloon dilation system, and its component parts, including any al (artificial intelligence software) may have malfunctioned and failed to perform as intended during the procedure performed on petitioner and that as a result the petitioner's carotid artery was injured.Since there was reported malfunctions with acclarent pivot navigation balloon dilation system but the information was reported with little to no information on what the failure was (defective/faulty device, etc.), the file is coded as unknown failure.If the device is returned they will be analyzed and tested, which may allow for the determination of a root cause for the failure/s.The patient experienced a carotid artery blew during the procedure with acclarent devices (acclarent pivot navigation balloon dilation system), which required additional intervention during and after the procedure, this event meets us fda reporting criteria under 21 cfr 803 with a classification of ¿serious injury.¿ 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 PIVOT NAVIGATION BALLOON DILATION SYSTEM
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer (Section G): CONFLUENT MEDICAL TECHNOLOGIES; coyol free zone, building 14; el coyol; alajuela 20201 ; CS 20201
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 17084123
• MDR Text Key: 316794695
• Report Number: 3005172759-2023-00034
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 10705031465596
• UDI-Public: 10705031465596
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVT0616N
• Device Catalogue Number: PVT0616N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female