MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. UNKNOWN_INSTRUMENTS_PRODUCT; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number UNK_INS

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

Patient Problem Loss of Vision (2139)

Event Date 11/01/2022

Event Type  Injury  

Manufacturer Narrative

Device not available.

Event Description

The manufacturer became aware of an event reported in the american journal of ophthalmology.The article states that upon inflation of the balloon into the left sphenoid sinus, there was a pulsatile bleeding encountered from the wall of the sinus.An emergency catheter angiography and a traumatic pseudoaneurysm was noted in the left internal carotid artery that required endovascular embolization.After the procedure visual changes were noted.Severe bleeding from the carotid artery that required endovascular embolization.After the procedures, the patient¿s visual acuity was 20/40 in the right eye and 20/200 in the left eye.The pupil exam revealed a left relative afferent pupillary defect.Visual field testing showed a central scotoma and an inferior nasal quadrant defect in the left eye.On fundus exam, there were multiple retinal emboli seen with ischemic retinal whitening in the left superior macular and superior temporal segments consistent with multifocal branch retinal artery occlusions in the left eye.No additional information was available to the manufacturer.

• Brand Name: UNKNOWN_INSTRUMENTS_PRODUCT
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• Manufacturer (Section G): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16022163
• MDR Text Key: 305880240
• Report Number: 3006345872-2022-00012
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNK_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2022
• 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
• Patient Outcome(s): Required Intervention