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 08/12/2021

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 first name, last name and email address of the initial reporter are not available / reported.He 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.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.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 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, functional endoscopic sinus revision hybrid procedure on (b)(6) 2021, the 2mm bulb tip of the acclarent pivot navigation balloon dilation system (pvt0616n / 82223847) broke off in the frontal sinus during septoplasty.The pivot balloon had been inflated four times before the issue with the bulb breaking off occurred.The bulb tip was successfully removed via sterile tweezers.The patient was stable; no harm was noted to the patient.The guide/balloon had not been flushed prior to use.It was also reported that the guidewire component in the balloon was kinked and would not slide easily back and forth.A new pivot balloon from the same lot (82223847) was opened and used to complete the case without any further incident.The reported issue resulted in less than 2 minutes delay; not clinically significant.There was no report of any patient adverse event or complication.

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 02 september 2021.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4) the purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during an in-office, functional endoscopic sinus revision hybrid procedure on (b)(6) 2021, the 2mm bulb tip of the acclarent pivot navigation balloon dilation system (pvt0616n / 82223847) broke off in the frontal sinus during septoplasty.The pivot balloon had been inflated four times before the issue with the bulb breaking off occurred.The bulb tip was successfully removed via sterile tweezers.The patient was stable; no harm was noted to the patient.The guide/balloon had not been flushed prior to use.It was also reported that the guidewire component in the balloon was kinked and would not slide easily back and forth.A new pivot balloon from the same lot (82223847) was opened and used to complete the case without any further incident.The reported issue resulted in less than 2 minutes delay; not clinically significant.There was no report of any patient adverse event or complication.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the acclarent pivot navigation balloon dilation system was received.Visual inspection was performed.It was observed that the complaint device was returned without the bulb tip.Additionally, the guidewire was observed kinked at the distal tip.The guidewire was removed from the device and another kink was observed near the proximal end of the wire slider.The complaint device was sent to the research and development lab for further evaluation due to the detached bulb tip.The investigation was unable to determine a conclusive root cause for the failure of the acclarent pivot tip.A review of the lot release data showed the manufacturing process of the impacted balloon catheter subassembly lots was very capable and producing devices with tip tensile strengths well above the minimum requirement of 4n.In addition, a review of the batch records did not reveal any manufacturing issues that would have contributed to the tip failure.Inspection of product from one of the impacted lots in finished goods inventory found no defective catheter bub tip welds.A visual analysis of the returned device conducted under high magnification showed evidence that the device was subjected to high force and tortuosity during the procedure which may have contributed to the failure.Also observed on the device was evidence pointing to a potentially inadequate laser bonding process which could have contributed to the failure as well however, similar characteristics were noted on 2 out 15 samples from lot release testing that had known tensile strengths well above the minimum requirement of 4n.To date, acclarent has shipped 800 units to customers and have one complaint for bulb tip falling off.Based on this, the calculated occurrence is 0.125% which does exceed the anticipated residual occurrence score, increasing the rating from 1 to 2 ¿ rare (< 1% and =.1%).Therefore, the acclarent pivot complaint reported is determined to be an isolated incident with an undetermined root cause.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.As part of acclarent quality process, all devices are manufactured, inspected, and released to approved specifications.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.

• 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: 12380853
• MDR Text Key: 274594323
• Report Number: 3005172759-2021-00011
• 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,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1