MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI SUCTION, 0 - 1PK; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Model Number TDNS000Z

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 12/23/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).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 product was received in the product analysis lab on (b)(6) 2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.A review of manufacturing documentation associated with this lot 2111120 presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.The reported csf leak event prompted the physician to performed intervention via the use of durgen and mucosal graft to patch up the injury site.The intervention was likely required to preclude permanent impairment of a body function or permanent damage to a body structure, the event meets mdr reporting criteria with the classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.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.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 revision endoscopic sinus surgery (ress) procedure on (b)(6) 2022, a penetration / puncture of the skull base next to the posterior ethmoid area occurred.It was reported that the 0° trudi nav suction device (tdns000z / 2111120) was displayed on the trudi system at 1cm from the skull base and the physician ¿ended up putting a hole in the skull base with the suction device.¿ it was reported that the physician thought he saw brain material under direct visualization with his surgical endoscope.The physician then worked in another area for ¿a little while¿ and when he checked again, brain material was still visible.When the physician placed the suction device at the point where he saw the brain matter, the trudi system still displayed the location of the suction device as 1cm from the site.It was reported that the physician performed medical intervention and ¿patched the hole¿ and the procedure was completed.The patient was discharged the next morning and was reported to be in stable condition.The physician believed that the trudi system was not accurate in its calibration or registration.It was reported that he was unsure if any other disposable devices had any accuracy issue.A medtronic shaver was also used during the procedure.The serial number of the trudi system is (b)(4).It was reported that evaluation / calibration of the system has been requested.The software version was confirmed as unknown.Field service engineer (fse) will be dispatched.On (b)(6) 2023, the director of medical affairs met with the attending physician regarding this case.The meeting is summarized below with responses to the additional information requested.This was a difficult revision case.The patient has recurrent fungal rhinosinusitis with poor anatomy.Registration was performed by the or nurse who traced with question on increased pressure on the skin.After registration, the physician noted it was normal when checking externally.However, it seemed more accurate on the right side than on the left.Responses to questions related to the adverse event, aside from patching up the injury site, the patient did not receive further medical and/or surgical intervention.The physician used durgen and mucosal graft to patch up the injury site.There was evidence of cerebrospinal fluid (csf) leak at the injury site.The information indicated that the patient had undergone previous procedures prior to this revision procedure.The patient has a history of fungal rhinosinusitis that needed the removal of the remaining ethmoid cells.The patient has had no additional procedures since the repair; the patient had one prior surgery before this procedure during which the incident occurred.The physician did not identify any defect in the skull base pre-operatively, however, intra-operative endoscopy noted defect after removing the posterior ethmoid cell.The patient is pending post-operative computed tomography (ct) scan.The information indicated that the patient was admitted to the hospital due to the reported event.The patient is reported to be doing well without any deficit and any further csf leak.There was no deficit / residual symptoms after the patient was discharged.The information indicated that the physician moved to the other side / nasal cavity before returning and still seeing brain material.The physician used the trudi suction device to work in the other side / nasal cavity, there was accuracy issue, but it was not as significant an issue as with accuracy issue on the contralateral side.The medtronic shaver was not used until after the reported adverse event had occurred; it was not used in the same area before the reported event with the injury to the skull base was observed.The physician did not suspect the medtronic shaver as a contributing factor to the reported adverse event.The endoscope used was a zero-degree stryker endoscope.Responses related to the accuracy issue with the trudi system were also provided.The software version used was not known.When the accuracy issue was observed, the icon on the trudi system was not seen.There was nothing seen with regards to any error message on the trudi nav monitor for the device.The trudi device was plugged in after registration.Regarding to whether the patient tracker moved or the patient tracker cable was under tension in relation to this event, the response provided was, ¿not that aware of any movement used tegaderm.¿ ct image was used as the primary image.The quantity of slices the ct scan contained was not provided; the cut was 1mm cuts.No ferromagnetic material was placed within the trudi zone.The crosshairs did not turn yellow.The emitter pad did not move; the patient did not move.No other devices¿ shafts were in the proximity to an emitter¿s pad¿s transmitter.On (b)(6) 2023, additional information was received from the acclarent ent representative.The information indicated that the software version used was version 2.3.The trudi suction device reprocessed approximately 17 times with steam sterilization method as per the instruction for use (ifu).Patient demographic is not available.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 0° trudi nav suction device was received contained in the decontamination pouch.Visual inspection was performed.There was no appearance of damage observed.The electrical functionality was tested, and the device was confirmed to be within specifications for all the connectivity and isolation values.The unit was sent to bwi-htc (haifa technology center) for magnetic calibration system (magcs) check.The unit passed the magcs calibration check.Per the results provided by the bwi-htc team, the reported issue documented in the complaint was not confirmed.The suction tool was found to be functional.A review of manufacturing documentation associated with this lot 2111120 presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of acclarent quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached as to what may have caused or contributed to the event reported, the instructions for use (ifu) states that before use, confirm the trudi¿ nav suction¿s location accuracy by checking the displayed position of the trudi¿ nav suction on several clearly identifiable anatomical structures.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: TRUDI SUCTION, 0 - 1PK
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer (Section G): VIANT MEDICAL; 45 lexington drive; laconia NH 03246
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 16199498
• MDR Text Key: 307661763
• Report Number: 3005172759-2023-00001
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: TDNS000Z
• Device Catalogue Number: TDNS000Z
• Device Lot Number: 2111120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 03/16/2023
• Supplement Dates FDA Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2021
• 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
• Treatment: FOESS® SINUSCOPE 0° (STRYKER); MEDTRONIC SHAVER
• Patient Outcome(s): Required Intervention