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 12/10/2015

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 rigid instrumentation.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): rigid instruments (unknown brand) and the medtronic straight-shot shaver used during the same procedure on (b)(6) 2015.

Event Description

Acclarent was informed of an event which occurred after a procedure in which a relieva spin balloon sinuplasty system was used.The hybrid frontal sinus revision surgery performed on (b)(6) 2015, in the or/asc, included a balloon sinuplasty (bsp).Rigid instruments of an unknown brand and the medtronic straight-shot shaver were said to have been used in addition to the acclarent products.A ct scan was ordered at the end of the bsp procedure and a csf (cerebrospinal fluid) leak was noticed.The patient was admitted to the hospital and the leak was stopped with the creation of a flap in the anatomy.The patient's current condition is not known.

• 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: 5358592
• MDR Text Key: 35607809
• Report Number: 3005172759-2016-00003
• 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: 01/11/2016
• 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: RS0616MFS
• 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): Hospitalization; Life Threatening; Required Intervention