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

Catalog Number RSP0616MFS

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 08/23/2017

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2017, the patient was at home and reported that the symptoms were getting better.The physician stated that the csf leak is ¿healing on its own.¿ the csf leak was diminishing and the pain levels were only 1-2 out of 10.On 08/30/2017, the physician reported that the patient had been seen at a medical center where it was noted that the csf leak had stopped; the patient continued with a ¿spinal¿ headache and a lumbar drain was placed.Regarding the reported csf leak, the physician stated that he does ¿not feel that the balloon was the cause¿; the physician also stated that he ¿thinks it was spontaneous and not caused by the device.¿ in addition, the spinplus balloon catheter functioned as expected during the procedure; there was no report of malfunction with any of the acclarent devices used during the balloon sinuplasty procedure.Concomitant medical products: medtronic fusion navigation system and probe.The acclarent products used during the procedure were said to have functioned as expected and the balloon sinuplasty procedure was completed as planned.No acclarent devices are available to be returned for evaluation as they were discarded by the user facility.The lot history record review could not be performed as lot number for the acclarent relieva spinplus device was unavailable.If additional information is received regarding this report, a supplemental report will be filed.(b)(4).

Event Description

Acclarent was informed of an event on (b)(6) 2017, the patient suffered a cerebrospinal fluid (csf) leak post balloon sinuplasty procedure.The patient underwent a primary balloon sinuplasty procedure on (b)(6) 2017, in which the acclarent relieva spinplus 6 mm, 3 guides kit was used along with the medtronic fusion navigation system and probe.The patient returned with symptoms on (b)(6) 2017.The physician reported that an immediate ct scan of the sinuses was performed and the post-operative ct scan showed no signs of dehiscence in the frontal, ethmoid, or sphenoid sinuses.The patient was prescribed decadron 4 mg intramuscular and antibiotics.The patient was instructed to keep the head elevated and not to blow the nose.Lastly, the patient had an appointment with a pain clinic for possible lumbar drain placement; however, no recommendation for a drain placement was made at the time.

• Brand Name: RELIEVA SPINPLUS
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ACCLARENT, INC.; 33 technology drive; irvine CA 92618
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 949789-383
• MDR Report Key: 6884771
• MDR Text Key: 87178991
• Report Number: 3005172759-2017-00051
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• 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: 08/24/2017

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: RSP0616MFS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2017
• Initial Date FDA Received: 09/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 25 YR