MAUDE Adverse Event Report: MEDTRONIC ENT BALLOON SEEKER FRNT 6X17MM; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number 1830617FRT

Device Problem Imprecision (1307)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2014

Event Type  malfunction  

Event Description

A medtronic ent representative reported that, while in an ear, nose & throat (ent) procedure, the site alleged an inaccuracy when navigating the sphenoid balloon.When plugging in the instrument and navigating, the tip of the balloon appeared to be multiple centimeters deeper than it actually was in the patient.Instruments other than the balloon seekers were all accurate.No specific measurements of the alleged inaccuracy, or further details of the procedure, were provided.The surgeon acknowledged the inaccuracy and opted to continue the procedure to completion, with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

(b)(4) 2014.A medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.This is a disposable device.No parts have been returned to manufacturer for analysis.

Manufacturer Narrative

Expiration date, lot number and associated manufacture date provided.

• Brand Name: BALLOON SEEKER FRNT 6X17MM
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): MEDTRONIC ENT; xomed headquarters; 6743 southpoint drive; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer Contact: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 4140170
• MDR Text Key: 15807114
• Report Number: 1723170-2014-01044
• 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: User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/08/2015
• Device Catalogue Number: 1830617FRT
• Device Lot Number: 0208437770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2014
• 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 Age: 45 YR
• Patient Weight: 102