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

Catalog Number RS0616M

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/27/2015

Event Type  malfunction  

Manufacturer Narrative

The returned package included: one (1) 6 x 16 mm spin balloon catheter along with the guide wire.The following observations were noted: the balloon was returned with the device.The balloon was detached from the catheter as reported.The inner shaft was exposed and noted to have a kink.The catheter was tested by connecting it to the sample inflation device, filled with water under pressure and water was observed to leak from the shaft open area.The reported complaint was confirmed.Product analysis was also conducted on the guide wire which was unrelated to the alleged complaint.The results were as follows: the returned guide wire did not have any abnormal observations upon visual examinations.The guide wire was connected to the xenon light source to verify the light output of the fibers.The light output was transmitted and the measurement was within specifications.A review of the lot history record for the subject device did not note any anomalies.

Event Description

Acclarent was informed that during a primary balloon sinuplasty procedure, the balloon catheter burst in the right frontal sinus.When the physician removed the spin device from the patient, he noticed that the balloon was missing.The physician reexamined the right frontal sinus and observed remnant of the balloon up near the frontal recess / ethmoid sinuses.A bayonet forceps was used to extract the balloon; the balloon remnant was removed successfully.A second relieva spin balloon sinuplasty system was opened to complete the procedure.There was no report of patient injury or complication.

• Brand Name: RELIEVA SPIN SINUPLASTY SYSTEM
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine CA
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497899383
• MDR Report Key: 6168022
• MDR Text Key: 62356273
• Report Number: 3005172759-2016-00020
• 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: company representative
• Reporter Occupation: Health Professional
• 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: 12/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2018
• Device Catalogue Number: RS0616M
• Device Lot Number: 150109G-CM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2015
• Date Device Manufactured: 01/14/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63