MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT

Catalog Number RSP0616MFSN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); No Code Available (3191)

Event Date 08/19/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The patient identifier was not provided.(b)(4).[conclusion]: the healthcare professional reported that during a primary hybrid balloon sinuplasty / ethmoidectomy / polypectomy procedure on (b)(6) 2019, targeting the left frontal sinus of a (b)(6) female patient with a history of sinus disease using the 6 x 16 mm relieva spinplus navigation balloon sinuplasty system (rsp0616mfsn / 190329a-pc), a cerebrospinal fluid (csf) leak was identified near the cribiform plate on the patient¿s left side.Pre-operative computed tomography (ct) scan revealed a pre-existing dehiscence of the skull base near the cribiform plate/bone.There was no difficulty in accessing the sinus.The physician began the procedure manually lateralizing the middle turbinates using a freer to gain access to the sphenoid outflow tract.The physician successfully dilated both the left and right sphenoid sinuses.He then medialized the middle turbinate with the freer and successfully access the left frontal sinus by identifying the lateral and posterior outflow tract, dilating and irrigating the sinus under direct endoscopic visualization.The device was deflated and removed from the left frontal sinus.The physician indicated he needed to re-enter the sinus to dilate inferiorly in the outflow tract to provide access/space for the intersect propel stent.The physician re-entered the sinus under direct endoscopic visualization and began searching for the outflow tract medial and anterior to the original dilation/outflow tract.The physician palpitated the area with the blue guide catheter tip to aid in his search as well as to advance the guide wire.The patient had a pre-existing skull base dehiscence at the medial and anterior aspect of the skull base and bone could not be appreciated/identified in this area of the anatomy via ct scan.The acclarent representative indicated to the physician that the tract was more posterior than lateral; the physician moved on to posterior and lateral search and gained access to sinus and dilated.The physician then placed a stent in the frontal outflow tract.The physician then successfully dilated the maxillary sinus.Another stent was placed in middle meatus/ethmoid, after using traditional steel instrumentation as well as relieva circa® ethmoid punch to remove ethmoid tissue.The physician moved on to right side and completed the same procedures as the left without issue.During the procedure, the acclarent representative approached the physician and requested an investigation of the patient¿s left frontal region for possible csf leak.The physician removed the frontal stent and middle meatus stent with rigid instrument and identified csf leak where the preexisting dehiscence/erosion of bone was located.The physician packed patient with proper products and completed the procedure as planned.Per follow up, the patient was stable after the procedure and stable as of (b)(6) 2019.It was confirmed that the guide catheter was not the cause of the reported csf leak; it was reported that the acclarent device functioned as expected without any malfunction.The patient did not have any co-morbidities that could have contributed to the reported event.The reported event did not result in hospitalization of the patient.Per relieva instruction for use (ifu), standard practice for endoscopic sinus surgery requires that appropriate radiographic imaging (e.G.Computed tomography (ct) scan) be reviewed prior to surgery to assess the development of sinus anatomy and compatibility with the sinus balloon catheter.Furthermore, the ifu instructs to never advance or retract the relieva® spin sinus guide catheter tip, or sinus balloon catheter against unknown resistance, as this could cause tissue trauma or device damage.Per reporter, the acclarent devices functioned as expected and the procedure was completed successfully.Per information provided, this adverse event was related to user error and not due to any device malfunction.Based on complaint information, the device was not available to be returned for analysis.Product analysis cannot be conducted as the product was not returned for analysis.The lot history record(s) was reviewed for lot 190329a-pc; no anomalies were found related to this complaint.In addition, the lhr review verifies that the device was manufactured in accordance with documented specification and procedures.Product analysis cannot be conducted as the product was not returned for analysis.There was no report of any device malfunction.As such, the investigation will be closed.There was no report of any product malfunction during the procedure.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 Description

The healthcare professional reported that during a primary hybrid balloon sinuplasty / ethmoidectomy / polypectomy procedure on (b)(6) 2019, targeting the left frontal sinus of a (b)(6) female patient with a history of sinus disease using the 6 x 16 mm relieva spinplus navigation balloon sinuplasty system (rsp0616mfsn / 190329a-pc), a cerebrospinal fluid (csf) leak was identified near the cribiform plate on the patient¿s left side.Pre-operative computed tomography (ct) scan revealed a pre-existing dehiscence of the skull base near the cribiform plate/bone.There was no difficulty in accessing the sinus.The physician began the procedure manually lateralizing the middle turbinates using a freer to gain access to the sphenoid outflow tract.The physician successfully dilated both the left and right sphenoid sinuses.He then medialized the middle turbinate with the freer and successfully access the left frontal sinus by identifying the lateral and posterior outflow tract, dilating and irrigating the sinus under direct endoscopic visualization.The device was deflated and removed from the left frontal sinus.The physician indicated he needed to re-enter the sinus to dilate inferiorly in the outflow tract to provide access/space for the intersect propel stent.The physician re-entered the sinus under direct endoscopic visualization and began searching for the outflow tract medial and anterior to the original dilation/outflow tract.The physician palpitated the area with the blue guide catheter tip to aid in his search as well as to advance the guide wire.The patient had a pre-existing skull base dehiscence at the medial and anterior aspect of the skull base and bone could not be appreciated/identified in this area of the anatomy via ct scan.The acclarent representative indicated to the physician that the tract was more posterior than lateral; the physician moved on to posterior and lateral search and gained access to sinus and dilated.The physician then placed a stent in the frontal outflow tract.The physician then successfully dilated the maxillary sinus.Another stent was placed in middle meatus/ethmoid, after using traditional steel instrumentation as well as relieva circa® ethmoid punch to remove ethmoid tissue.The physician moved on to right side and completed the same procedures as the left without issue.During the procedure, the acclarent representative approached the physician and requested an investigation of the patient¿s left frontal region for possible csf leak.The physician removed the frontal stent and middle meatus stent with rigid instrument and identified csf leak where the preexisting dehiscence/erosion of bone was located.The physician packed patient with proper products and completed the procedure as planned.Per follow up, the patient was stable after the procedure and stable as of (b)(6) 2019.It was confirmed that the guide catheter was not the cause of the reported csf leak; it was reported that the acclarent device functioned as expected without any malfunction.The patient did not have any co-morbidities that could have contributed to the reported event.The reported event did not result in hospitalization of the patient.

• Brand Name: RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT
• Type of Device: RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ACCLARENT, INC.; 33 technology drive; irvine CA 92618
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9041309
• MDR Text Key: 158704433
• Report Number: 3005172759-2019-00123
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10705031241015
• UDI-Public: 10705031241015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2020
• Device Catalogue Number: RSP0616MFSN
• Device Lot Number: 190329A-PC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 66