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| Model Number TDNS070Z |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
Hemorrhage/Bleeding (1888)
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| Event Date 05/02/2023 |
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Event Type
Injury
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Event Description
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The ent consultant reported that during an ent procedure on (b)(6) 2023, that employed the use of the following acclarent devices: a 70° trudi nav suction device (tdns070z / lot# unknown), a 0° trudi nav suction device (tdns000z / lot# unknown), a 90° trudi nav suction devices (tdns090z / lot# unknown), and a trudi navigation shaver blade (tsb4str / 230214a-pc) an adverse event occurred.The patient suffered a cerebrospinal fluid (csf) leak during the procedure.It was reported that the csf leak did not take place during the device during navigation, however, they were using trudi navigation during the procedure.No instruments were being used when the adverse event was noticed.The ent consultant also reported that during the procedure, they also got into the other side of the lamina (the orbit) of the patient when they noticed that there was a dehiscent.It was reported that orbital fat had punctured out of that area.There was a large polyp within the middle meatus of the nose and when the physician was shaving, it was so thin and so close to the orbit, that the yellow fatty portion of the orbit was ¿hanging out¿ and the physician then noticed the dehiscence.It was reported that the patient had no symptoms at this time and the dehiscence was confirmed through computed tomography (ct) scan.The physician also reported that the patient has a low cribriform plate.It was reported that the physician noted that he did not believe the perforation had anything to do with the navigation, ¿that it was just poor anatomy.¿ the physician had not re-registered during the case when he was asked if he was happy with the accuracy, he responded that, ¿(at this point), he was not sure anymore.¿ the physician reiterated that he did not believe it had to do with the navigation, but with the anatomy of the patient.Prior to the start of the procedure, when the physician registered, ¿everything looked good.¿ there was no intervention provided at the time.The ent consultant reported that there was a lot of bleeding from the dehiscent.The physician went back with an instrument to cauterize the bleeding and when he went to cauterize the problem area, he cauterized too much, puncturing the tissue, causing fluid to come out.It was then that the physician noticed the csf leak.It was reported that the physician patched the leak and the csf fluid was no longer coming out.The patient was discharged to home in stable condition.Later in the evening on (b)(6) 2023, the patient went to the hospital due to bleeding.The ent consulted reported that the hospital staff recognized the source of the bleed, they packed the patient¿s nose, and the patient was sent home.The patient was admitted again the following week (unknown date) due to having symptoms of meningitis.It was reported that the patient saw another physician who then scheduled surgery to patch the csf leak.The ent consultant reported that ¿it sounded like the csf leak started again.¿ the patient is reported to be in stable condition and had been scheduled for the csf repair procedure (date unknown) at a different facility with a new physician.On 17-may-2023, additional information was received from the ent consultant.The information indicated that the procedure on (b)(6) 2023, was targeting the frontal and bilateral maxillary sinuses.The patient had not undergone previous procedures on or around the skull base.The physician did not identify any defect in the skull base preoperatively.The csf leak was observed during suction cautery; the device used when the csf leak was observed was a suction cautery.The information indicated that the low cribiform plate did factor into the csf leak.The source of the csf leak was identified, however, the response provided by the ent consultant was, ¿yes, surgeon can answer location.¿ the location of the dehiscent was not in the same area as the csf leak; the csf leak was on the left; lamina was on the right.Regarding any negative impact to the patient¿s orbit in the area where the dehiscent was observed, the orbit fat was observed by the surgeon coming from the orbit.The dehiscent was not a result of the shaving of the polyp with the trudi 4mm navigation blade.The information indicated that the surgeon had mentioned the system was slightly off around 3mm during the time of use with the navigation system, suctions and shaver blade were used during the procedure.The fluid that came out when the physician ¿cauterized too much puncturing the tissue¿ was csf fluid.The reported csf leak was a contributing factor to the meningitis.The information indicated that per the physician¿s opinion, the cause of the csf leak was suction cautery and the patient¿s anatomy.Later in the evening of the procedure, when the patient went to the hospital, no additional medical intervention was performed to further pack the area that was bleeding.On 22-may-2023, additional information was received from ent consultant.The information indicated that the source/location of the csf leak was identified and the response on the location is pending the physician.The lot numbers for the suction devices are not available.Related to the question, ¿was there any issue related to accuracy (or other performance issues) at any time during the procedure (if yes, please provide the instruments that had the accuracy / performance issue)?¿ the response received was, ¿as i gathered more information from the case, the system appeared to working fine during the procedure.The surgeon mentioned the system could had been slightly off during the case, but not enough where the surgeon felt he needed to reregister the patient to obtain better accuracy.The 4.0 mm blade was used during the case as well as the zero degree suction.The csf leak was created during the time of using the suction cautery and the navigation was not being used during that time.¿ on 23-may-2023, additional information was received, the information indicated that, ¿upon further investigation there was no confirmed inaccuracy that could be confirmed during the case.¿ on 30-may-2023, additional information was received.The information indicated that accuracy was confirmed using the registration probe after the registration process was completed.The end user did confirm accuracy of known landmarks in endoscopic visualization inside the nasal cavity.The physician performed the registration.The information indicated that this was the physician¿s second time performing registration, and ¿upon further investigation, accuracy was not determined to be an issue during the case.¿ the patient was discharged from the index procedure but came back the same day / night for the bleeding.The patient¿s condition is reported to be ¿improved.¿.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, weight, race, and ethnicity were not provided.Section d.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.Section e.1: the initial reporter phone is not available / reported.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.Based on complaint information, the device is 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 information available and without the complaint product available to be returned for analysis, the reported issue in the complaint cannot be confirmed.The lot number of the device is not known; therefore, manufacturing documentation review not performed.According to the information provided, it was confirmed that the use of the acclarent devices were not the cause of the csf leak.The doctor attributed the cause of the csf leak to the use of the suction cautery device (manufacturer is unknown), it was also confirmed by the physician that the reported csf leak was a contributing factor to the meningitis.Thus, it is reasonable to assume that used acclarent devices were not the cause of the csf leak and meningitis.Since the patient experienced profuse hemorrhage during the procedure with acclarent devices (trudi navigation 4mm blade and trudi nav suction devices 0-degree tip angle, 70-degree tip angle, and 90-degree tip angle), which required additional medical intervention during and after the procedure, the event meets us fda reporting criteria under 21 cfr 803 with the classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.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 4 products involved with the reported complaint.The associated manufacturer report numbers are: 3005172759-2023-00030, 3005172759-2023-00031, 3005172759-2023-00032, and 3005172759-2023-00033.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.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.
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