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 02/18/2022

Event Type  malfunction  

Event Description

The healthcare professional reported that during a primary functional endoscopic sinus surgery (fess) procedure, when the scrub tech snipped off the blue tip of the acclarent pivot navigation balloon dilation system (pvt0616n / 82228108) and tried to retract the balloon, the balloon became detached from the device.Then when the replacement balloon, another acclarent pivot navigation balloon dilation system (pvt0616n / 82228108) was being prepped, the scrub tech forgot to unlock the balloon and the wire and when she sniped the tip of the balloon off, the wire was inadvertently snipped rendering the device unusable.A third balloon was opened and used to the complete the procedure.There was no report of any patient adverse event or complication.On 22-feb-2022, additional information was provided.The information indicated that during the first incident, when the scrub tech snipped the tip and retracted the balloon, the balloon had not been used yet.It was out of the package so it was fully deflated prior to retraction.The tip was cut immediately after opening the device.The entire balloon component was sheared off when the balloon was retracted; the acclarent ent consultant reported that he has the pivot device did not get the actual balloon section that fell off as it was a darker room and the balloon piece went under a sterile table.It was confirmed that the balloon was not inflated as part of the prep process.The inflation device was not prepped nor attached at the time the balloon catheter was being prepped.The balloon catheter was not flushed as per the instruction for use (ifu), which states that during device prep, the balloon is supposed to be inflated to 2 atm and flushed with saline prior to cutting the tip.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Procode is pgw/lrc/pnz.Device evaluated by mfr: the 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 (82228108) 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.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received by the product analysis lab on 09-mar-2022.The return product is pending evaluation.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 a primary functional endoscopic sinus surgery (fess) procedure, when the scrub tech snipped off the blue tip of the acclarent pivot navigation balloon dilation system (pvt0616n / 82228108) and tried to retract the balloon, the balloon became detached from the device.Then when the replacement balloon, another acclarent pivot navigation balloon dilation system (pvt0616n / 82228108) was being prepped, the scrub tech forgot to unlock the balloon and the wire and when she sniped the tip of the balloon off, the wire was inadvertently snipped rendering the device unusable.A third balloon was opened and used to the complete the procedure.There was no report of any patient adverse event or complication.On 22-feb-2022, additional information was provided.The information indicated that during the first incident, when the scrub tech snipped the tip and retracted the balloon, the balloon had not been used yet.It was out of the package so it was fully deflated prior to retraction.The tip was cut immediately after opening the device.The entire balloon component was sheared off when the balloon was retracted; the acclarent ent consultant reported that he has the pivot device did not get the actual balloon section that fell off as it was a darker room and the balloon piece went under a sterile table.It was confirmed that the balloon was not inflated as part of the prep process.The inflation device was not prepped nor attached at the time the balloon catheter was being prepped.The balloon catheter was not flushed as per the instruction for use (ifu), which states that during device prep, the balloon is supposed to be inflated to 2 atm and flushed with saline prior to cutting the tip.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the complaint device was received.Visual inspection was performed.The distal portion of the balloon shaft of the pivot nt was not returned.Microscopic inspection was performed on the remaining catheter shaft.Thermal marks of the welding from the balloon to the shaft were observed at the distal edge, indicating proper manufacturing.Additionally, marks on the surface of the shaft suggest that the damage was made with a sharp instrument, however this cannot be conclusively determined.Furthermore, guide tip was inspected, and it was found to be in good and normal conditions.No contributing factors were identified.Customer complaint was confirmed due to the findings observed.However, the event description and device analysis do not provide clear insight into the root cause and/or exact contributing factors that may have resulted in the observed failure mode.A review of manufacturing documentation associated with this lot (82228108) 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.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.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: 13691425
• MDR Text Key: 296850519
• Report Number: 3005172759-2022-00004
• 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,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2022
• Device Model Number: PVT0616N
• Device Catalogue Number: PVT0616N
• Device Lot Number: 82228108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2021
• 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