MAUDE Adverse Event Report: ACCLARENT, INC. TDP0005; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Model Number TDP0005

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.The device lot number is not available / not reported.The expiration date of the device is not known.The initial reporter email was not reported / available.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.The device manufacture date is not known as the device lot number is not available / not reported.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 primary balloon sinuplasty procedure, the trudi probe (tdp0005 / lot#: unknown) for the trudi nav system broke; this occurred while using the bending tool.There was no difficulty in removing the probe from the patient¿s body.The broken probe was replaced, and the procedure was resumed to completion.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 multiple attempts to obtain product for analysis and obtain additional information were unsuccessful.If product is returned or information provided at a later date, the file will be updated accordingly.[conclusion]: the healthcare professional reported that during an in-office primary balloon sinuplasty procedure, the trudi probe (tdp0005 / lot#: unknown) for the trudi nav system broke; this occurred while using the bending tool.There was no difficulty in removing the probe from the patient¿s body.The broken probe was replaced, and the procedure was resumed to completion.There was no report of any patient adverse event or complication.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 limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.In addition, without a lot number to conduct a manufacturing documentation review, it is not possible to determine if the reported failure could be related to the manufacturing process.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; however, it is possible that clinical and procedural factors may have contributed to the reported issue.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.Updated sections: g.3, g.6, h.2, h.3, h.6, and h.10.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: TDP0005
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• MDR Report Key: 10805062
• MDR Text Key: 217160554
• Report Number: 3005172759-2020-00007
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 10705031464193
• UDI-Public: 10705031464193
• Combination Product (y/n): N
• PMA/PMN Number: K193453
• 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: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TDP0005
• Device Catalogue Number: TDP0005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1