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 03/03/2022

Event Type  malfunction  

Event Description

The healthcare professional reported that during an in-office primary balloon sinuplasty (bsp) procedure, the blue ball tip fell off from the acclarent pivot navigation balloon dilation system (pvt0616n / 82232425) after dilation.There was no report of any patient adverse event or injury associated with the reported event.The complaint device is available for return.On 04-mar-2022, additional information was provided from the acclarent sales representative to the acclarent principal quality engineer via phone.The information indicated that an important detail was not added to the complaint.Per the acclarent sales representative, ¿the scrub tech never removed the red protective sheath.When the doctor retracted the balloon and articulated to 110 degrees, the protective sheath was still on the balloon.That red protective sheath was also still on the catheter when the device was inserted into the patient.¿ on 07-mar-2022, additional information was received.The information indicated that the procedure was targeting all six sinuses.When the blue ball tip fell off the balloon, the procedure was not yet complete, the physician dilated one of the six intended sinuses.The left maxillary sinus was the sinus treated with the complaint device.In order to complete the case, the physician opened up a new balloon catheter, another pivot device (pvn0616n) to complete the procedure.The information confirmed that the tip fell off on the surgical field, not in the patient.Non-acclarent device used was an endoscope with camera.The reported event did not result in any clinically significant delay in the procedure.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Procode is pgw/lrc/pnz.Product analysis lab has received the complaint device on (b)(6) 2022.A supplemental 3500a report will be submitted once the product investigation has been completed.A review of manufacturing documentation associated with this lot (82232425) 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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during an in-office primary balloon sinuplasty (bsp) procedure, the blue ball tip fell off from the acclarent pivot navigation balloon dilation system (pvt0616n / 82232425) after dilation.There was no report of any patient adverse event or injury associated with the reported event.The complaint device is available for return.On 04-mar-2022, additional information was provided from the acclarent sales representative to the acclarent principal quality engineer via phone.The information indicated that an important detail was not added to the complaint.Per the acclarent sales representative, ¿the scrub tech never removed the red protective sheath.When the doctor retracted the balloon and articulated to 110 degrees, the protective sheath was still on the balloon.That red protective sheath was also still on the catheter when the device was inserted into the patient.¿ on 07-mar-2022, additional information was received.The information indicated that the procedure was targeting all six sinuses.When the blue ball tip fell off the balloon, the procedure was not yet complete, the physician dilated one of the six intended sinuses.The left maxillary sinus was the sinus treated with the complaint device.In order to complete the case, the physician opened up a new balloon catheter, another pivot device (pvn0616n) to complete the procedure.The information confirmed that the tip fell off on the surgical field, not in the patient.Non-acclarent device used was an endoscope with camera.The reported event did not result in any clinically significant delay in the procedure.The complaint product was returned and received for evaluation and analysis.The investigational finding is documented below.Investigation summary: the complaint device was returned for evaluation.Visual inspection was performed.The acclarent pivot navigation balloon dilation system was returned with the blue bulb tip and the red protective sheath in a separate bag.Further inspection revealed marks of physical damage on the bulb tip and the balloon catheter, suggesting that it was ripped off.Evidence of the laser bonding were observed around the balloon catheter and the blue bulb tip.In addition, the red protective sheath was observed kinked through its length with one of the ends observed slightly compressed.Based on the damaged observed on the returned complaint device, the customer complaint was confirmed.With the evidence available, it is suspected that the use of the device with the red protective sheath still on it contributed to the failure, however this cannot be conclusively determined.It should be noted that product failure could be caused by multiple factors.However, instructions for use states to remove the red protective balloon sheath covering the balloon during preparation of the device.A review of manufacturing documentation associated with this lot (82232425) 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
• Manufacturer (Section G): CONFLUENT MEDICAL TECHNOLOGIES; coyol free zone, building 14; el coyol; alajuela 20201 ; CS 20201
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 13840825
• MDR Text Key: 295794139
• Report Number: 3005172759-2022-00005
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2022
• Device Model Number: PVT0616N
• Device Catalogue Number: PVT0616N
• Device Lot Number: 82232425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2021
• 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