MAUDE Adverse Event Report: ACCLARENT, INC. UNKNOWN

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Visual Impairment (2138)

Event Date 08/20/2015

Event Type  Injury  

Manufacturer Narrative

Acclarent is unable to confirm whether the product used in the procedure was manufactured by acclarent or what other tools may have been used, such as those used for functional endoscopic sinus surgery (fess).There was no indication of any product malfunction.It is also not known whether the procedure was performed at the same facility where the reporting physician works.A different physician at this facility was known to have performed an adenoid and balloon sinuplasty procedure on a (b)(6) male using a acclarent products approximately one week prior.However, it is unknown if this patient was the one that had the issue with "looking up." the subject device was not available for evaluation, and its whereabouts are unknown.If additional information is received, a supplemental report will be filed.Acclarent will continue to monitor this phenomenon for trending purposes.

Event Description

Acclarent was informed of an event in which a patient was said to have had difficulty "looking up" following an adenoid and balloon sinuplasty procedure using unknown devices.The reporting physician stated that the patient's difficulty in "looking up" allegedly occurred following a procedure performed by a second unnamed physician in which an unidentified brand and model of balloon catheter had been used.It was reported that the patient's mother had come to the reporting physician for a consultation sometime after the procedure.Acclarent has attempted to contact the reporting physician to obtain additional information related to the event, but has received no further details of the occurrence, or the status of the patient.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• 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: 5112793
• MDR Text Key: 27100790
• Report Number: 3005172759-2015-00014
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2015
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR