MAUDE Adverse Event Report: INTERSECT ENT, INC. PROPEL; DRUG-ELUTING SINUS STENT

Model Number 70011

Device Problems Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2021

Event Type  malfunction  

Event Description

Young adult female was having an outpatient procedure to treat chronic sinusitis.While using the propel sinus implant 23mm during the case, during the deployment process, the spindles on the implant were not releasing from the deployment device.The pusher inside the deployment piece appeared to be pinching the implant and not allowing it to release.The surgeon was able to get the implant out of the delivery system, but that process affected the implant itself.This error occurred with two different devices.This is a single-use, disposable item.There was no harm to the patient.The surgeon felt there was an issue with deployment due to manufacturer error with the device, but the product representative felt it was potentially operator error when loading the propel stent in the device.Plan is to re-train staff.

• Brand Name: PROPEL
• Type of Device: DRUG-ELUTING SINUS STENT
• Manufacturer (Section D): INTERSECT ENT, INC.; 1555 adams drive; menlo park CA 94025
• MDR Report Key: 11553059
• MDR Text Key: 241787297
• Report Number: 11553059
• Device Sequence Number: 1
• Product Code: OWO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/16/2021

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: 70011
• Device Catalogue Number: 70011
• Device Lot Number: 90920001 AND 91106003
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13140 DA