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

Model Number N/A

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Material Rupture (1546)

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

Event Date 09/25/2015

Event Type  Injury  

Manufacturer Narrative

The subject device is pending return for evaluation.Review of manufacturing records associated with the subject device did not detect any anomalies.A supplemental report will be submitted when the product is returned and tested.Acclarent will continue to monitor this phenomenon for trending purposes.

Event Description

Acclarent was made aware of an event that occurred during a procedure in which an acclarent relieva spin balloon sinuplasty system was used.During the primary bilateral maxillary balloon sinuplasty procedure (bsp) along with septoplasty and turbinate surgery, there was no difficulty reported in accessing the patient's sinus cavities.Upon the first inflation of the acclarent relievapin balloon, the balloon was said to have ruptured and become detached, falling into the patient's maxillary sinus cavity.The surgeon performed an antrostomy to retrieve the balloon, and confirmed that all pieces were successfully removed.There was no other intervention required, and the procedure was completed using another acclarent relievapin balloon sinuplasty system.The patient was reported to have been doing well with no sequelae reported following the procedure.

Manufacturer Narrative

Acclarent received the package on 2/24/2016.The returned package included the following items: a spin sinuplasty balloon, luma sentry wire, balloon slider, wire slider, detachable connector, guide catheter (m-110).Upon receiving the package, before decontamination, the product was visually inspected and it was observed that the tip of the guide catheter was kinked, part of the balloon was missing, the tip of balloon catheter was damaged and inner shaft of balloon catheter was kinked.No product analysis could be performed due part of the balloon being missing.The customer complaint has been verified.

• Brand Name: RELIEVA SPIN BALLOON SINUPLASTY DEVICE
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 1525-b o'brien dr; menlo park CA
• Manufacturer Contact: izabel nielson ; 1525-b o'brien dr; menlo park, CA 94025 ; 6506877492
• MDR Report Key: 5174910
• MDR Text Key: 29212010
• Report Number: 3005172759-2015-00015
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2018
• Device Model Number: N/A
• Device Catalogue Number: RS0616MFS
• Device Lot Number: 150811C-CM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention