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

Model Number PVT0616N

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Procode is pgw/lrc/pnz.The initial reporter email address is not available / reported.[conclusion]: the healthcare professional reported that during an in-office primary balloon sinuplasty (bsp) procedure on (b)(6) 2021, the blue tip of the acclarent pivot navigation balloon dilation system (pvt0616n / 82223847) came off while the device was inside the ethmoid sinus.The physician was able to retrieve the blue tip from the ethmoid sinus via suction.It was reported that there were no issues with the patient anatomy.A new balloon system was opened to continue the procedure.There was no report of any patient adverse event or complication due to the reported issue.The complaint device is not available to be returned.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (82223847) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product evaluation and analysis cannot be conducted as the product was not available to be returned.Determination of causes and possible contributing factors could not be made.As such, the investigation will be closed.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined.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.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.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 an in-office primary balloon sinuplasty (bsp) procedure on (b)(6) 2021, the blue tip of the acclarent pivot navigation balloon dilation system (pvt0616n / 82223847) came off while the device was inside the ethmoid sinus.The physician was able to retrieve the blue tip from the ethmoid sinus via suction.It was reported that there were no issues with the patient anatomy.A new balloon system was opened to continue the procedure.There was no report of any patient adverse event or complication due to the reported issue.The complaint device is not available to be returned.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 05-oct-2021 and to make a correction to section g.3 of the initial medwatch report.[additional information]: the healthcare professional reported that during an in-office primary balloon sinuplasty (bsp) procedure on 09 september 2021, the blue tip of the acclarent pivot navigation balloon dilation system (pvt0616n / 82223847) came off while the device was inside the ethmoid sinus.The physician was able to retrieve the blue tip from the ethmoid sinus via suction.It was reported that there were no issues with the patient anatomy.A new balloon system was opened to continue the procedure.There was no report of any patient adverse event or complication due to the reported issue.On 05-oct-2021, the clinical associate who was present during the procedure was contacted by representatives from the marketing and quality engineering for additional information.The clinical associate stated that the bulb tip was initially cut using the provided trimmer prior to starting the case.The physician performed the cutting as instructed in the instructions for use (ifu).The physician first used the pivot device to dilate the right and then the left sphenoid sinuses using four (4) dilations before proceeding to the right frontal sinus.The physician noticed that the blue ring on the distal tip that remained after cutting fell into the ethmoid sinus and was able to use suction to remove it.The device was then replaced and the case continued without further incident.Correction: the date received by manufacturer in the initial report was documented as 10-sept-2021.The correct date is 09-sept-2021.This corrected date also correct the submission due date of the initial report from 10-oct-2021 to 09-oct-2021.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.Correction: the date received by manufacturer in the initial report was documented as 10-sept-2021.The correct date is 09-sept-2021.This corrected date also correct the submission due date of the initial report from 10-oct-2021 to 09-oct-2021.

• 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
• MDR Report Key: 12579757
• MDR Text Key: 278220240
• Report Number: 3005172759-2021-00014
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 10705031465596
• UDI-Public: 10705031465596
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2022
• Device Model Number: PVT0616N
• Device Catalogue Number: PVT0616N
• Device Lot Number: 82223847
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1