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

Catalog Number RS0616F

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

Patient Problem No Code Available (3191)

Event Date 03/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot history record (lhr) was reviewed and no anomalies were found related to this complaint.In addition, the lhr review verifies that the device was manufactured in accordance with documented specification and procedures.

Event Description

Acclarent was informed of an event which occurred on (b)(6) 2016, during a frontal and maxillary procedure in which a relieva spin balloon sinuplasty's system was used.After the physician completed the procedure, the physician checked the patient and noticed an anterior fossa / cranial crack.The physician sealed the crack and reported that the issue may have occurred because of the thin bones in the patient's anatomy.The patient was given a diuretic and placed on bed rest and was reported as 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: 5568778
• MDR Text Key: 42371611
• Report Number: 3005172759-2016-00006
• 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: 03/22/2016

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 Catalogue Number: RS0616F
• Device Lot Number: 151021A-PC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2016
• 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): Other