MAUDE Adverse Event Report: INTERSECT ENT PROPEL MINI SINUS IMPLANT

Model Number 60011

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Choking (2464)

Event Date 06/10/2015

Event Type  malfunction  

Event Description

A female patient underwent bilateral endoscopic sinus surgery with turbinate reduction along with septoplasty in which drug eluting sinus implants were placed bilaterally in the ethmoid sinus post-operatively.12 days post placement, the patient phoned the physician to report the implant on the right side had migrated to her throat when she sneezed causing her to gag, a temporary sensation.The patient retrieved the implant with ease by reaching into her mouth/throat with her hand.The patient was reported to have no subsequent issues post event and no additional medical intervention was required.The same day, the patient was seen by the physician who decided to remove the left side implant.

Manufacturer Narrative

Based on the company's complaint investigation, the device was used according to labeled indications.In an abundance of caution, intersect ent is reporting this event as a malfunction based on the information it received and the remote possibility of serious injury should a similar event occur.

• Brand Name: PROPEL MINI SINUS IMPLANT
• Manufacturer (Section D): INTERSECT ENT; menlo park CA
• Manufacturer Contact: amy wolbeck ; 1555 adams dr; menlo park, CA 94025 ; 6506412115
• MDR Report Key: 4913328
• MDR Text Key: 21089068
• Report Number: 3010101669-2015-00003
• Device Sequence Number: 1
• Product Code: OWO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60011
• Device Catalogue Number: 60011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2015
• Initial Date FDA Received: 07/10/2015
• 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: Initial
• Patient Sequence Number: 1