MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM - 1PK; BALLOON, NASAL AIRWAY

Model Number	RT1640AZ
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Decreased Sensitivity (2683)
Date of Event	07/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, race, and ethnicity were not provided.The device lot number is not available / not reported.The expiration date of the device is not known.The initial reporter email is not available / reported.The device manufacture date is not known as the device lot number is not available / not reported.Conclusion: the healthcare professional reported that the (b)(6) female patient with a history of hypothyroidism underwent primary procedures in the following order: bilateral partial inferior turbinate reduction, balloon septoplasty, image guidance, bilateral frontal balloon sinuplasty, bilateral sphenoid balloon sinuplasty, bilateral maxillary balloon sinuplasty ending with bilateral frontal propel contour placement and posisep x placement adjacent to the turbinate incisions on (b)(6) 2021, using the 16 x 40 mm relieva tract balloon dilation system (rt1640az / unknown lot#) suffered from instant, persisting numbness and sensory loss in the hard / soft palate.The patient was placed on oral steroid prednisone and it was discussed with the physician of a possible neurological consultation versus possibly starting the patient on gabapentin to help reduce the sensory nerve irritation.The patient is currently in stable condition with persistent palate numbness.During the procedure, it was reported that while the relieva tract balloon was being inflated in the patient¿s right-side septum, the patient ¿jumped¿ and stated that she felt pain then numbness in the hard / soft palate.The balloon catheter was in the nasal cavity with the balloon positioned inferior to the middle turbinate.The physician held the tip of the balloon anterior to the nasal vestibule outside of the anterior nasal cavity.The physician assured the patient that no incisions were made as scalpel cutting the nerve was not performed.The physician believes that the event is related to a sensory nerve injury apparently in the region of the balloon expansion as a nerve was hit when the balloon expanded.At present, the patient continues to experience numbness in the same area and feels like she ¿burned the roof of her mouth with a hot piece of pizza.¿ as of 31 august 2021, the patient¿s status is still stable and has not changed.The patient did not have any previous sinus surgeries or previous trauma to the region where the balloon was dilated.The patient has a medical history of hypothyroidism in which the only medication she takes is to treat the hypothyroidism.The physician performed the bilateral partial inferior turbinate reductions using the 1st generation bien air micro-debrider (bien air surgery) prior to the balloon dilation.The patient had no discomfort and did not notice pain during these procedures.There was an anterior incision, then the cottle septum elevator (novo surgical) was used to create a submucosal channel for the microdebrider tip.During the procedure, for all six sinuses, non-acclarent xpress¿ ent dilation system (entellus medical) was used and for turbinate work, the physician used the 1st generation bien air micro-debrider.The relieva tract was used first in the line-up of procedures.The relieva tract balloon functioned as expected and the procedure continued and successfully completed without replacing the device.There were no challenges accessing the intranasal space during the procedure and only local anesthesia was used.Based on complaint information, the device was 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.As per the instructions for use (ifu), the relieva tract¿ balloon dilation system is an instrument intended to provide increased intranasal space to facilitate access for endonasal and trans-nasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum.This device is contraindicated in gross anatomic abnormalities or congenital anomalies involving the central craniofacial skeleton, significant deformities of the caudal septum and dorsal septal deviations contributing to external nasal deformity, deformities of the nasal septum involving excessively thickened or gross excesses of cartilage or bone.It is cautioned to never advance or retract the device against unknown resistance, as this could cause tissue trauma or device damage and to check for proper position of the balloon catheter using endoscopic visualization.Balloon inflation in an improper location may lead to patient injury.Furthermore, use of a balloon catheter that is too large for the targeted anatomy may cause damage to the surrounding anatomy.The root cause of the event cannot be conclusively determined; however patient and procedural factors, and / or operator technique may have contributed to the reported event of numbness and sensory loss.Since the physician alleged this event is causally related to the acclarent device and procedure and the event required medication intervention to preclude further injury, the event meets mdr reporting criteria.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.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 or Problem Description
The healthcare professional reported that the (b)(6) female patient with a history of hypothyroidism underwent primary procedures in the following order: bilateral partial inferior turbinate reduction, balloon septoplasty, image guidance, bilateral frontal balloon sinuplasty, bilateral sphenoid balloon sinuplasty, bilateral maxillary balloon sinuplasty ending with bilateral frontal propel contour placement and posisep x placement adjacent to the turbinate incisions on (b)(6) 2021, using the 16 x 40 mm relieva tract balloon dilation system (rt1640az / unknown lot#) suffered from instant, persisting numbness and sensory loss in the hard / soft palate.The patient was placed on oral steroid prednisone and it was discussed with the physician of a possible neurological consultation versus possibly starting the patient on gabapentin to help reduce the sensory nerve irritation.The patient is currently in stable condition with persistent palate numbness.During the procedure, it was reported that while the relieva tract balloon was being inflated in the patient¿s right-side septum, the patient ¿jumped¿ and stated that she felt pain then numbness in the hard / soft palate.The balloon catheter was in the nasal cavity with the balloon positioned inferior to the middle turbinate.The physician held the tip of the balloon anterior to the nasal vestibule outside of the anterior nasal cavity.The physician assured the patient that no incisions were made as scalpel cutting the nerve was not performed.The physician believes that the event is related to a sensory nerve injury apparently in the region of the balloon expansion as a nerve was hit when the balloon expanded.At present, the patient continues to experience numbness in the same area and feels like she ¿burned the roof of her mouth with a hot piece of pizza.¿ as of 31 august 2021, the patient¿s status is still stable and has not changed.The patient did not have any previous sinus surgeries or previous trauma to the region where the balloon was dilated.The patient has a medical history of hypothyroidism in which the only medication she takes is to treat the hypothyroidism.The physician performed the bilateral partial inferior turbinate reductions using the 1st generation bien air micro-debrider (bien air surgery) prior to the balloon dilation.The patient had no discomfort and did not notice pain during these procedures.There was an anterior incision, then the cottle septum elevator (novo surgical) was used to create a submucosal channel for the micro-debrider tip.During the procedure, for all six sinuses, non-acclarent xpress¿ ent dilation system (entellus medical) was used and for turbinate work, the physician used the 1st generation bien air micro-debrider.The relieva tract was used first in the line-up of procedures.The relieva tract balloon functioned as expected and the procedure continued and successfully completed without replacing the device.There were no challenges accessing the intranasal space during the procedure and only local anesthesia was used.

• Brand Name: RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM - 1PK
• Common Device Name: BALLOON, NASAL AIRWAY
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• MDR Report Key: 12410529
• Report Number: 3005172759-2021-00012
• Device Sequence Number: 4459855
• Product Code: QGK
• UDI-Device Identifier: 20705031462653
• UDI-Public: 20705031462653
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Type of Report: Initial
• Report Date (Section B): 08/18/2021

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 Model Number: RT1640AZ
• Device Catalogue Number: RT1640AZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Weight: 113