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 Respiratory Tract Infection (2420)

Event Date 12/12/2015

Event Type  Injury  

Event Description

Acclarent was informed of an event on (b)(6) 2016, which occurred on (b)(6) 2015, during a balloon sinuplasty in-office (bspio) procedure in which the patient experienced an adverse reaction.During the procedure the patient was administered 30 mg of liquid versed (midazolam).Later in the procedure the patient was reported to have struggled to remain conscious.The physician was able to successfully dilated both frontal sinuses and right maxillary sinus.The patient was bleeding heavily from the nose and appeared to have soiled himself and aspirated on his vomit.The physician attempted to clear the patient's airway with a yankauer suction and attempted to administer oxygen to the patient.Emergency medical service (ems) was dispatched by 911 service.The patient was reported to have low oxygen saturation (~80%) but was stable and semi-conscious.The patient was transported via ambulance to the hospital.There was no reported malfunction with any of the acclarent products used during the case.Thus, this event is unrelated to the devices and most likely related to the procedure or patient's pre-existing condition.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: 5387005
• MDR Text Key: 36704475
• Report Number: 3005172759-2016-00004
• 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: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2016
• 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; Other; Required Intervention
• Patient Age: 70