MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPIN SINUPLASTY SYSTEM; INSTRUMENT, ENT MANUAL SURGICAL

Model Number N/A

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 12/08/2015

Event Type  Injury  

Manufacturer Narrative

The age and weight of the patient are not known.The acclarent products used during the procedure were said to have functioned as normal and the bsp procedure was completed as planned.The physician noted that the suspected cause of the csf (cerebrospinal fluid) leak was the removal of the polyp using the shaver blade.No acclarent devices are available to be returned for evaluation as they were discarded by the user facility.If additional information is received regarding this report, a supplemental report will be filed.Acclarent will continue to monitor this phenomenon for trending purposes.Concomitant medical products and therapy dates (exclude treatment of event): unknown brand of rigid seeker, back-biter, and shaver used during the same procedure on (b)(6) 2015.

Event Description

Acclarent was informed of an event which occurred during a procedure in which a relievapin balloon sinuplasty system was used.The hybrid procedure performed on (b)(6) 2015 included balloon sinuplasty (bsp) along with an ethmoidectomy, polypectomy, and a maxillary antrostomy.A rigid seeker, back-biter, and a shaver were said to have been used in addition to the acclarent products.The bsp portion of the procedure was said to have been completed and then the shaver was used to remove a polyp.Sometime thereafter, a csf (cerebrospinal fluid) leak was noticed, and the area was packed with surgicell.Upon the completion of the procedure, the patient's condition was noted to have been normal with no reported neurologic deficits.It is not known if the patient required any further intervention or hospitalization.

• Brand Name: RELIEVA SPIN SINUPLASTY SYSTEM
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine CA
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497899383
• MDR Report Key: 5354425
• MDR Text Key: 35459179
• Report Number: 3005172759-2016-00002
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RS0616F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention