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 No Code Available (3191)

Event Date 04/30/2015

Event Type  Injury  

Manufacturer Narrative

The age of the patient is not known.The weight of the patient is not known.(b)(4).No acclarent devices are available to be returned for evaluation as they were discarded by the user facility.The lot history record (lhr) review was not performed as the lot number was not available.If additional information is received regarding this report, a supplemental report will be filed.(b)(4).

Event Description

Acclarent was informed on 05/03/2016, that the physician who performed the in-office balloon sinuplasty procedure was reported to the (b)(6) medical board for a procedure he performed on (b)(6) 2015, in which a relieva spin balloon sinuplasty system was used.The physician stated that the patient made it through the procedure but started to bleed.The patient did not require packing but bled, gagged, vomited, aspirated and became hypoxemic.Emergency service was called via 911 and the patient was admitted to the hospital for 5 days where the patient was intubated.Further follow-up on the patient status provided the following information: the patient suffered a heart attack and was intubated for several days but the patient did recover.

• 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: 5682091
• MDR Text Key: 46003746
• Report Number: 3005172759-2016-00011
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• 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; Required Intervention