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

Catalog Number RSP0616MFS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

The lhr (lot history record) review of the device cannot be performed as lot number was unavailable.If additional information is received regarding this report, a supplemental report will be filed.

Event Description

Acclarent was informed on 11/16/2016, of an event which occurred during a procedure on (b)(6) 2016, in which a relieva® spinplus kit, 3 guides, 6x16mm, 5pk was used.During the treatment of the right maxillary sinus, on the second irrigation of the sinus using 60 cc of saline, the irrigation process was met with high resistance.The nurse had to apply a lot of pressure on the syringe during the irrigation.At that time, the surgeon noticed that the patient¿s eye was protruding from the eye socket.Surgical repair was performed and the patient was moved to recovery.The patient is reported to be doing well without any residual orbital or vision issues.A follow-up scan was performed to compare with the initial prep scan showed no operative invasion into the orbit.There was no reported malfunction with the relieva® spinplus kit used during the case.

• Brand Name: RELIEVA SPINPLUS 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: 6168091
• MDR Text Key: 62186454
• Report Number: 3005172759-2016-00023
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143541
• 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: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RSP0616MFS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2016
• 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?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR