MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI PROBE, 0, 5IN; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Model Number TDP0005

Device Problem Material Separation (1562)

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

Event Date 06/04/2021

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 name, phone and email address of the initial reporter are not available / reported.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.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 procedure on (b)(6) 2021, the 0-degree trudi probe (tdp0005 / lot# unknown) was used with the acclarent pivot navigation balloon dilation system (pvt0616n / lot# unknown), the shaft of the trudi probe came apart and separated (the distal end separated from the proximal portion that connect to the handle.The guidewire on the pivot navigation balloon also became slightly kinked.The case was reportedly completed without any patient adverse event or complication.On 10 june 2021, additional information was received indicating that the procedure was a primary balloon sinuplasty (bsp) procedure.The shaft of the trudi probe came apart and separated as reported during the treatment of the maxillary sinus.No pieces from the separated shaft fell into the patient¿s anatomy.There was no injury to the nasal nor sinus tissue from the reported issue with the trudi probe shaft.The trudi probe had been used once during this procedure when the issue with the shaft was encountered.There was no difficulty in accessing the sinus with the pivot balloon catheter; it had been used in other sinuses during the procedure prior to the guidewire becoming kinked.There was procedure delay as a result of the reported issue; the procedure was successfully completed without 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 12 july 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 a procedure on 04 june 2021, the 0-degree trudi probe (tdp0005 / lot# unknown) was used with the acclarent pivot navigation balloon dilation system (pvt0616n / lot# unknown), the shaft of the trudi probe came apart and separated (the distal end separated from the proximal portion that connect to the handle.The guidewire on the pivot navigation balloon also became slightly kinked.The case was reportedly completed without any patient adverse event or complication.On 10 june 2021, additional information was received indicating that the procedure was a primary balloon sinuplasty (bsp) procedure.The shaft of the trudi probe came apart and separated as reported during the treatment of the maxillary sinus.No pieces from the separated shaft fell into the patient¿s anatomy.There was no injury to the nasal nor sinus tissue from the reported issue with the trudi probe shaft.The trudi probe had been used once during this procedure when the issue with the shaft was encountered.There was no difficulty in accessing the sinus with the pivot balloon catheter; it had been used in other sinuses during the procedure prior to the guidewire becoming kinked.There was procedure delay as a result of the reported issue; the procedure was successfully completed without any patient adverse event or complication.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the trudi probe was returned for evaluation.Visual inspection was performed.The complaint device was found with no appearance of physical damage.The shaft was observed in good condition.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.As part of acclarent quality process all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.However, the instructions for use (ifu) states that excessive bending / unbending the distal tip or altering the trudi¿ probe stainless steel shaft may adversely impact the performance of the device or result in patient harm.The event reported in the complaint could not be confirmed.The trudi probe was returned without any appearance of damage noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The lot number of the device is not known, therefore review of the device history record was not performed.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: TRUDI PROBE, 0, 5IN
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• MDR Report Key: 12034569
• MDR Text Key: 263229431
• Report Number: 3005172759-2021-00007
• 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,Followup
• Report Date: 06/04/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 07/12/2021; 07/28/2021
• Supplement Dates FDA Received: 07/12/2021; 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACCLARENT PIVOT NAVIGATION BALLOON DILATION SYSTEM