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 05/31/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, weight, and ethnicity were not provided.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 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.A review of manufacturing documentation associated with this lot (2112140) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3005172759-2022-00012.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.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 acclarent representative reported that a male patient suffered a cerebrospinal fluid (csf) leak during a primary bilateral functional endoscopic sinus surgery (fess) procedure.It was reported that after registration of the device, everything looked accurate.The physician completed the procedure on the patient¿s left side with no issues.The physician proceeded to do a septoplasty procedure on the right side, at this point in the procedure, the acclarent representative stepped out of the room.The representative was called back into the room by the physician when they discovered the csf leak.It was reported that in the physician¿s opinion, ¿they had entered the skull base thinking it was the ethmoid cell.¿ it was reported that the physician ¿packed it¿ (the csf leak) and used duracil on it.The physician then completed the procedure and the patient was sent to the hospital for a computed tomography (ct) scan and observation.As of the time of the call, the acclarent representative reported that the physician was told by the emergency surgeon that the ct scan ¿looked fine¿ and the patient was ¿responding well.¿ the acclarent representative reported that after the csf leak was discovered, they used fam and a 0° trudi nav suction device ((b)(4) / lot#: 2112140 / sn: (b)(4)) and 70° trudi nav suction device ((b)(4) / lot#:2110167 /sn: (b)(4)) to map the same spot; the mapping was reported to be accurate.Then they used the registration probe and it showed accuracy on the patient¿s forehead.They tested the mapping accuracy at the back of the maxillary sinus using both the zero-degree and the 70-degree suction tool and they noted the mapping was off by 2mm.They then proceeded to test to see the difference between where the skull base dehiscence was and where the mapping system indicated it was and it appeared the mapping was off by 9mm.When the physician was asked, it was his opinion that the inaccuracy of the mapping data that contributed to the injury that was made with a rigid through-cut tool (non-acclarent device).On 03-jun-2022, the acclarent representative provided responses to additional information request.It includes the following correction to the event description: ¿when asked it was the physician's opinion that the inaccuracy of the mapping data contributed to the injury that was made with a rigid through-cut tool (not an acclarent tool).¿ per the entc, ¿the surgeon took the zero degree to (what we know now was skull base), trudi showed it at the bottom of an ethmoid cell.He then took a ball probe and poked the cell, then he took thru-cut forceps and removed tissue to expose the csf leak.¿ there was nothing noticeable before the case related to any defect in the skull base preoperatively.The physician noticed the leak intra-operatively.The packing and the use of the duracil was effective in stopping the reported csf leak.¿the patient was dry at the time of transport.¿ the procedure was completed before the patient was sent to the hospital.The additional information indicated that the patient did stay overnight in the hospital for observation; the patient has since been discharged.The rigid (non-acclarent) device used was the thru-cut forceps.The zero-degree and the 70-degree suction tools mapping were off by 2mm in the maxillary sinus.Both suction tools showed 9mm off when they were tested to see the difference between the skull base dehiscence was and where the mapping system indicated.It was the zero-degree trudi suction tool that was being used with the rigid thru-cut forceps when the csf leak was observed.The icon on the trudi system was green when the accuracy issue was observed for both zero and 70 degree suction tools.No error message was displayed for either suction tools.Both the zero degree and the 70 degree suction tools were plugged in the device after registration (i.E., using the registration probe).It was not noticeable whether the patient tracker moved or the patient tracker cable was under tension in relation to this event (this is applicable to both zero and 70 degree tools).Computed tomography (ct) image was used as the primary image for both zero and 70 degree suction tools.The ct scan contains an estimated 250.4mm slices.There was no ferromagnetic material placed with the trudi zone for either the zero degree or the 70 degree suction tool.The crosshairs did not turn yellow for the zero degree or the 70 degree suction tool.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 19-jun-2022.The information indicated that the complaint device is not available to be returned for evaluation and analysis.[conclusion]: the acclarent representative reported that a male patient suffered a cerebrospinal fluid (csf) leak during a primary bilateral functional endoscopic sinus surgery (fess) procedure.It was reported that after registration of the device, everything looked accurate.The physician completed the procedure on the patient¿s left side with no issues.The physician proceeded to do a septoplasty procedure on the right side, at this point in the procedure, the acclarent representative stepped out of the room.The representative was called back into the room by the physician when they discovered the csf leak.It was reported that in the physician¿s opinion, ¿they had entered the skull base thinking it was the ethmoid cell.¿ it was reported that the physician ¿packed it¿ (the csf leak) and used duracil on it.The physician then completed the procedure and the patient was sent to the hospital for a computed tomography (ct) scan and observation.As of the time of the call, the acclarent representative reported that the physician was told by the emergency surgeon that the ct scan ¿looked fine¿ and the patient was ¿responding well.¿.The acclarent representative reported that after the csf leak was discovered, they used fam and a 0° trudi nav suction device (tdns000z / lot#: 2112140 / sn: (b)(6) and 70° trudi nav suction device (tdns070z/ lot#:2110167 /sn: (b)(6) to map the same spot; the mapping was reported to be accurate.Then they used the registration probe and it showed accuracy on the patient¿s forehead.They tested the mapping accuracy at the back of the maxillary sinus using both the zero-degree and the 70-degree suction tool and they noted the mapping was off by 2mm.They then proceeded to test to see the difference between where the skull base dehiscence was and where the mapping system indicated it was and it appeared the mapping was off by 9mm.When the physician was asked, it was his opinion that the inaccuracy of the mapping data that contributed to the injury that was made with a rigid through-cut tool (non-acclarent device).On 03-jun-2022, the acclarent representative provided responses to additional information request.It includes the following correction to the event description: ¿when asked it was the physician's opinion that the inaccuracy of the mapping data contributed to the injury that was made with a rigid through-cut tool (not an acclarent tool).¿ per the entc, ¿the surgeon took the zero degree to (what we know now was skull base), trudi showed it at the bottom of an ethmoid cell.He then took a ball probe and poked the cell, then he took thru-cut forceps and removed tissue to expose the csf leak.¿ there was nothing noticeable before the case related to any defect in the skull base preoperatively.The physician noticed the leak intra-operatively.The packing and the use of the duracil was effective in stopping the reported csf leak.¿the patient was dry at the time of transport.¿ the procedure was completed before the patient was sent to the hospital.The additional information indicated that the patient did stay overnight in the hospital for observation; the patient has since been discharged.The rigid (non-acclarent) device used was the thru-cut forceps.The zero-degree and the 70-degree suction tools mapping were off by 2mm in the maxillary sinus.Both suction tools showed 9mm off when they were tested to see the difference between the skull base dehiscence was and where the mapping system indicated.It was the zero-degree trudi suction tool that was being used with the rigid thru-cut forceps when the csf leak was observed.The icon on the trudi system was green when the accuracy issue was observed for both zero and 70 degree suction tools.No error message was displayed for either suction tools.Both the zero degree and the 70 degree suction tools were plugged in the device after registration (i.E., using the registration probe).It was not noticeable whether the patient tracker moved or the patient tracker cable was under tension in relation to this event (this is applicable to both zero and 70 degree tools).Computed tomography (ct) image was used as the primary image for both zero and 70 degree suction tools.The ct scan contains an estimated 250.4mm slices.There was no ferromagnetic material placed with the trudi zone for either the zero degree or the 70 degree suction tool.The crosshairs did not turn yellow for the zero degree or the 70 degree suction tool.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (2112140) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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 available and without the complaint product available to be returned for analysis, the reported inaccuracy issue, and the icon on the trudi system was green when the accuracy issue was observed could not be investigated and could not be confirmed with product evaluation and analysis.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the information provided and without the return of the complaint sample.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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3005172759-2022-00012.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 include the additional event information received on 26-jul-2022 and to include two concomitant instruments that were not included in the initial medwatch.[additional information]: on 26-jul-2022, additional information was received.The information indicated that the arthrex tower and the storz tower were also used during the procedure.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3005172759-2022-00011 and 3005172759-2022-00012.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.The blakesley thru-cut forcep (integra lifesciences) and the ball probe were not included in the concomitant products in the initial medwatch report.They have been added in this mdr supplemental report as the correction.

• Brand Name: TRUDI SUCTION, 0 - 1PK
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine 92618
• Manufacturer (Section G): VIANT MEDICAL; 45 lexington drive; laconia NH 03246
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14700728
• MDR Text Key: 294944008
• Report Number: 3005172759-2022-00011
• 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,Followup
• Report Date: 07/26/2022

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: 2112140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/15/2022
• Supplement Dates Manufacturer Received: 06/19/2022; 07/26/2022
• Supplement Dates FDA Received: 06/24/2022; 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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: ARTHREX TOWER (ARTHREX).; BALL PROBE.; BLAKESLEY THRU-CUT FORCEP (INTEGRA LIFESCIENCES).; STORZ TOWER (KARL STORZ).
• Patient Outcome(s): Hospitalization
• Patient Sex: Male
• Patient Race: White