MAUDE Adverse Event Report: ACCLARENT, INC.

Lot Number UNK-ACC

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 02/03/2015

Event Type  Injury  

Event Description

Acclarent was informed of an event in which a patient was said to have developed a cerebrospinal fluid (csf) leak 2 months after a primary hybrid fess and balloon sinuplasty procedure in which an unknown acclarent balloon catheter was used.The reporting physician stated that the procedure was performed on (b)(6) 2015, and no complications were reported.The patient contacted the surgeon and reported clear fluid dripping from her nose 2 months following the procedure.The patient was referred to the er and subsequently transferred to an alternate hospital where she was diagnosed with a csf leak.The leak was reported to have been repaired, and it was noted that the physician had not determined the cause of the csf leak.Acclarent has attempted to contact the reporting physician to obtain additional information related to the event, but has received no further details regarding the event or the status of the patient.

Manufacturer Narrative

Acclarent products were said to have been used during the procedure, along with rigid instruments, but the type of acclarent devices is not known.The cause of the csf leak is unknown.No devices are available to be returned for evaluation.If additional information is received regarding this report, a supplemental report will be filed.Acclarent will continue to monitor this phenomenon for trending purposes.

• Brand Name: UNK
• Type of Device: UNK
• Manufacturer (Section D): ACCLARENT, INC.; 1525-b o'brien drive; menlo park CA
• Manufacturer Contact: izabel nielson ; 1525-b o'brien drive; menlo park, CA 94025 ; 6506877492
• MDR Report Key: 4799893
• MDR Text Key: 5921818
• Report Number: 3005172759-2015-00010
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNK-ACC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: (B)(6) 2015 - UNKNOWN TYPE OF RIGID INSTRUMENTS
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention