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 Problems Unspecified Infection (1930); Pain (1994); Staphylococcus Aureus (2058)

Event Date 11/01/2015

Event Type  Injury  

Manufacturer Narrative

The weight of the patient is not known.The acclarent products used during the procedure were said to have functioned as normal and the procedure was completed as planned.The sterility of the acclarent products used during the procedure was confirmed.The physician noted that she suspected the infection was a result of contaminated saline irrigation that was used post-operatively.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.

Event Description

Acclarent was informed of an event in which a patient was said to have reported severe facial pain at a post-operative visit on an unknown date, following balloon sinuplasty (bsp) procedure performed on (b)(6) 2015.An acclarent relieva spin 6x16 slnuplasty system was said to have been used during the procedure.The patient was diagnosed with an acute sinus infection during the post-operative visit.A culture was taken from the sinuses at that time and it came back as pan-sensitive staphylococcus aureus.The following day, the patient was admitted to the hospital due to vomiting and near-syncope, and was found to have blood cultures positive for staph.The treatment provided to the patient is not known.It was reported that the patient was discharged from the hospital on an unknown date and was said to have recovered and is doing well.

• 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: 5337126
• MDR Text Key: 34736389
• Report Number: 3005172759-2015-00020
• 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: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2018
• Device Model Number: N/A
• Device Catalogue Number: RS0616MFS
• Device Lot Number: 150701B-CM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 45 YR