MAUDE Adverse Event Report: ACCLARENT RELIEVA SPIN SINUPLASTY SYSTEM; SINUS BALLOON CATHETER

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

Patient Problem Pneumonia (2011)

Event Date 02/12/2014

Event Type  Injury  

Event Description

Acclarent was notified on (b)(4) 2014 of a domestic event that occurred on (b)(6) 2014 during a sinus surgical case when acclarent balloon dilation technology was used.(b)(6) female who was on coumadin for atrial fibrillation.She had a history of chronic cough, sinusitis and pseudomonas infection of the lungs.Because of the failure of intravenous antibiotics, persistent sinusitis and complicated medical problems, the physician elected to perform an in office balloon sinuplasty.The physician opened the maxillary and frontal sinuses bilaterally.Also, he opened the outflow with irrigation of the maxillary and frontal sinuses bilaterally with findings of significant purulent secretions.The procedure was without any adverse events.Over the next few days the pt became weak and short of breath.She went to an emergency department where bilateral pneumonia was diagnosed.She was hospitalized for several days and discharged to an extended care facility where she is doing well.

Manufacturer Narrative

Vp of medical affairs reviewed this event and spoke by phone to the treating physician to obtain additional info.The treating physician indicated that it is difficult to know when the pneumonia begin.It could have been present prior to his procedure and manifest by the cough present before the balloon sinuplasty procedure, could have occurred or worsened during the procedure with aspiration of purulent secretions or have occurred after surgery during the recovery.Vp of medical affairs concluded that there is not enough info to determine if the acclarent balloon devices contributed to the event of the pneumonia.The hospitalization and use of antibiotics was for pneumonia and not for an adverse event of the actual balloon sinuplasty procedure.The subject device of this report was not returned for evaluation, and its whereabouts are unk.Acclarent will continue to monitor this phenomenon for trending purposes.This report is being submitted in an abundance of caution.

• Brand Name: RELIEVA SPIN SINUPLASTY SYSTEM
• Type of Device: SINUS BALLOON CATHETER
• Manufacturer (Section D): ACCLARENT; menlo park CA
• Manufacturer Contact: monica barrett ; 1525-b o'brien dr.; menlo park, CA 94025 ; 6506874948
• MDR Report Key: 3690589
• MDR Text Key: 19926196
• Report Number: 3005172759-2014-00006
• 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: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2014
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ACCLARENT VORTEX IRRIGATION SYSTEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR