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U.S. Department of Health and Human Services

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

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ACCLARENT, INC. RELIEVA SPIN SINUPLASTY SYSTEM INSTRUMENT, ENT MANUAL SURGICAL Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem
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.

 
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Brand NameRELIEVA SPIN SINUPLASTY SYSTEM
Type of DeviceINSTRUMENT, 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 Key5387005
Report Number3005172759-2016-00004
Device Sequence Number1
Product CodeLRC
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 Received01/22/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberRS0616MFS
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/22/2016 Patient Sequence Number: 1
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