MAUDE Adverse Event Report: MEDTRONIC XOMED INC. INFLATOR KIT 18INFKIT BALLOON; INSTRUMENT, ENT MANUAL SURGICAL

Model Number 18INFKIT

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

Patient Problem Eye Injury (1845)

Event Date 07/21/2014

Event Type  Injury  

Event Description

An mdt sales rep reported the following: during a balloon sinus case using the nuvent balloon and malleable suction, the surgeon noticed that the eye on the side that they were performing the surgery on (right) started to swell.The surgeon was using the malleable suction tube attached to a 60ml syringe of saline to irrigate the sinuses.Each sinus (frontal and sphenoid) had been ballooned and was irrigated approximately 4 times with this method.After irrigation, the surgeon began to work on penetration of the posterior ethmoid bone/cell with the m4 and trackable tricut blade.Per the sales rep, the surgeon worked on this for about 45 minutes, and more than once commented about the difficulty she was having with penetrating the bone, and had to "really lean on it." at about 45 minutes of work, eye swelling was noticed.The procedure was immediately stopped, and the surgeon performed an emergency lateral canthotomy.After the lateral canthotomy, the rep noted that there was one drop/streak of blood, presumably from the cut made, and the orbit appeared "watery" as if the patient had tears.It is unknown if this was irrigation fluid or tears from eye manipulation.An ophthalmologist was called in.The surgeon later reported that the patient could see and eye pressure was normal.It was also noted that the surgeon was using a different manufacturer¿s scope irrigator, and she felt it put out an excessive amount of saline (500 cc¿s).

Manufacturer Narrative

This device is used for therapeutic purposes.Concomitant devices: balloon seeker 1830617frt em frnt 6x17mm, 510k: k132297, lot # 0208412034, manufactured date: 2014-06-03, use-by/expiration date: 2015-11-30; balloon seeker 1830717sph em sphn 7x17mm, 510k: k132297, lot #: 0208433140, manufactured date: 2014-06-10, use-by date/ expiration: 2015-12-07; ent instrument 9735016 (malleable suction tube), lot #: 140530j pump 1991005 endo-scrub 2, 510k: k982594 microdebrider 1898200t igs m4, 510k: k041413 ent endo p/n unknown (tricut blade).(b)(4).The products were not returned for analysis.Method: no testing methods performed.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: INFLATOR KIT 18INFKIT BALLOON
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: amy corrales ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328138
• MDR Report Key: 4011953
• MDR Text Key: 4705785
• Report Number: 1045254-2014-00188
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2015
• Device Model Number: 18INFKIT
• Device Catalogue Number: 18INFKIT
• Device Lot Number: 0208433059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00034 YR