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

Catalog Number RS0616F

Device Problems Burst Container or Vessel (1074); Inflation Problem (1310)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2014

Event Type  malfunction  

Event Description

Acclarent was notified on (b)(6) 2014 of a domestic event that occurred on (b)(6) 2014 during a sinus surgical case when acclarent balloon dilation technology was used.Physician inserted a guide catheter with a deflated balloon into the sinus.Physician instructed the technician to inflate balloon to 12 atm.At 8 atm the pressure in the inflation device dropped to 0.At that point the technician attempted to reprime the inflation device.When he hooked up to the tubing to the balloon again, the balloon was not inflated.Another inflation was opened and connected to the balloon catheter but balloon was not inflated also.The balloon was removed from the pt and it appeared that a portion of the balloon was ripped.The physician used a scope to see what the problem was and used the up blakesly forceps to attempt to remove a portion of the balloon.The physician was unable to retrieve the piece during the procedure.There was no pt injury and the pt was discharged and a f/u scan is scheduled.

Manufacturer Narrative

The device was unavailable for return device investigation.Per sales rep, as of (b)(6) 2014, the scan has not been performed.The medwatch form will be updated if add'l info becomes available.Acclarent will continue to monitor this phenomenon for trending purposes.This report is being submitted in 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: 3745482
• MDR Text Key: 4223493
• Report Number: 3005172759-2014-00003
• 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: 02/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RS0616F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2014
• 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: UP BLAKESLY FORCEPS; ACCLARENT FRONTAL GUIDE CATHETER