MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI SUCTION, 0 - 1PK; TRUDI NAV SUCTION, 0

Model Number TDNS000Z

Device Problem Incorrect Interpretation of Signal (1543)

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

Event Date 07/01/2021

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.The device lot number is not available / not reported.The trudi device does not have an expiration date; it is not a single use device.Trudi¿ suction instruments are supplied non-sterile and must be cleaned and sterilized prior to each usage.The name, phone and email address of the initial reporter are not available / reported.The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: the healthcare professional reported that during a primary hybrid functional endoscopic sinus surgery (fess) procedure, the 0° trudi nav suction device (tdns000z / s/n: unknown / lot#: unknown) was inaccurate.Attempt to re-register was not successful.It was also reported that the acclarent pivot navigation balloon dilation system (pvt0616n / lot# unknown) was also inaccurate.The physician continued on with the procedure and the case was successfully completed without using navigation.There was no report of any patient adverse event or complication.On 08 july 2021, additional information was received.The information indicated that when the issue with the suction device occurred, the icon on the trudi system was green.There was no error message.The device was plugged in after registration.This issue was noticed in the first use.The patient tracker was not moved nor was the patient tracker under tension in relation to this event.The device was not dropped nor mishandled.On 21 july 2021, additional information was received.The information indicated that the device was registered correctly and was functioning with no error message.The tip was present but it was inaccurate.The device was inside the patient¿s nasal cavity when the issue occurred.The 0° trudi nav suction device was not tired on another trudi system to confirm accuracy.The complaint device is reported as not available to be returned for evaluation and analysis.Based on complaint information, the device was 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 provided in the complaint and without the product available for analysis, the reported issues by the customer cannot be confirmed.The lot number of the device is not known, therefore review of the device history record was not performed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device.It is possible that clinical and procedural factors including device handling, device interaction, device selection and concomitant devices may have contributed to the reported accuracy issue related to the 0° trudi nav suction device.As part of acclarent quality process, all devices are manufactured, inspected, and released to approved specifications.An internal corrective and preventive action (capa) has been opened to further investigate the issue of loss of accuracy as related to suction tools.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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 a primary hybrid functional endoscopic sinus surgery (fess) procedure, the 0° trudi nav suction device (tdns000z / s/n: unknown / lot#: unknown) was inaccurate.Attempt to re-register was not successful.It was also reported that the acclarent pivot navigation balloon dilation system (pvt0616n / lot# unknown) was also inaccurate.The physician continued on with the procedure and the case was successfully completed without using navigation.There was no report of any patient adverse event or complication.On 08 july 2021, additional information was received.The information indicated that when the issue with the suction device occurred, the icon on the trudi system was green.There was no error message.The device was plugged in after registration.This issue was noticed in the first use.The patient tracker was not moved nor was the patient tracker under tension in relation to this event.The device was not dropped nor mishandled.On 21 july 2021, additional information was received.The information indicated that the device was registered correctly and was functioning with no error message.The tip was present but it was inaccurate.The device was inside the patient¿s nasal cavity when the issue occurred.The 0° trudi nav suction device was not tired on another trudi system to confirm accuracy.The complaint device is reported as not available to be returned for evaluation and analysis.

• Brand Name: TRUDI SUCTION, 0 - 1PK
• Type of Device: TRUDI NAV SUCTION, 0
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer (Section G): VIANT MEDICAL; 45 lexington drive; laconia NH 03246
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12222083
• MDR Text Key: 263607206
• Report Number: 3005172759-2021-00008
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 10705031245877
• UDI-Public: 10705031245877
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TDNS000Z
• Device Catalogue Number: TDNS000Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1