MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI SHAVER BLADE 4.0MM - STRAIGHT (0°)- 5PK; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	TSB4STR
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section d2b: pgw/erl.Section d.4: the expiration date of the device is not known as the device lot number is not available / not reported.The device was discarded; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.Based on the details of the event, the patient experienced serious injury (profusion bleeding) that resulted in additional medical and surgical intervention required, this complaint is considered reportable as a serious injury.There are no reported malfunctions with any acclarent devices used during the case.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.
Event or Problem Description
It was reported that a patient who underwent ent (ear, nose & throat procedure) with accelerant devices (trudi shaver blade 4.0mm - straight (0°)- 5pk) experienced profusion bleeding.It was reported while shaving with the trudi 4mm shaver blade in the sphenoid sinus the doctor hit "something" and the patient started bleeding profusely.It was also reported that the physician had to pack the patient's nose and suction the blood out of the mouth.Caller stated after the bleeding stopped, they removed the packing and the patient started bleeding profusely again so they repacked the patient's nose and did not remove it.It was reported that the patient was kept intubated and then sent them with ems to the emergency room.It was also noted that the accuracy on the trudi navigation system had no issues with accuracy and worked as intended.Additional event information was received on nov 22, 2023, per the information provided it was determined from a ct scan of the patient that the surgeon had hit the carotid.The surgeon also mentioned that there was a dehiscence near the skull base that was detected after the adverse event occurred.It was noted that the patient is doing well with no complications.Originally woke with stroke like symptoms but doing very well according to the surgeon as of today.

• Brand Name: TRUDI SHAVER BLADE 4.0MM - STRAIGHT (0°)- 5PK
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer (Section G): PRECISION CONCEPTS COSTA RICA; saret industrial park building; rio segundo; alajuela 90109 ; CS 90109
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18258778
• Report Number: 3005172759-2023-00066
• Device Sequence Number: 11763980
• Product Code: ERL
• UDI-Device Identifier: 10705031469235
• UDI-Public: 10705031469235
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K221037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: TSB4STR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown