MAUDE Adverse Event Report: ACCLARENT, INC. UNKNOWN

Catalog Number 99999S10

Device Problem Device Issue (2379)

Patient Problem No Code Available (3191)

Event Date 01/01/2009

Event Type  Injury  

Manufacturer Narrative

The event date is not known.The physician reported that the procedure was performed in 2009.No acclarent device was returned for evaluation.If additional information is received regarding this report, a supplemental report will be filed.

Event Description

On (b)(6) 2017, acclarent received an email from a physician regarding a procedure that was performed in 2009, in which a microflow spacer was placed in the patient.The patient returned for the one month removal and the spacer could not be found.The patient subsequently underwent revision surgery by another surgeon in 2015, and the spacer was found.The physician stated that the patient claimed that it was the broken balloon used at the time of the surgery and not a spacer.The surgeon who performed the second surgery also confirmed that it was a broken balloon with a metallic wire, most likely a guide wire.Per the device information for use (ifu), the relieva stratus microflow spacer is indicated for use as a postoperative spacer to maintain an opening to the ethmoid or frontal sinuses within the first 14 days following surgery.".

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine CA
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497899383
• MDR Report Key: 6350631
• MDR Text Key: 68089334
• Report Number: 3005172759-2017-00003
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 99999S10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other