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 12/26/2014

Event Type  malfunction  

Event Description

A medtronic representative reported that, while in an ear, nose & throat (ent), the surgeon alleged an inaccuracy with the frontal balloon.The surgeon was concerned that the frontal balloon was 2 millimeters off, compared to their navigating ostium seeker.The surgeon was able to visualize the frontal ostium; the balloon appeared slightly off when the navigating ostium seemed accurate.The surgeon opted to continue the procedure using their balloon, by relying on the visual endoscopic image.The procedure was completed without the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Patient identifier, age and weight were not made available from the site.Device manufacturing date is unavailable.Investigation completed, findings are that the balloon tool passed the system accuracy test.No further issues have been reported.

Manufacturer Narrative

(b)(4).

• 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: 4433949
• MDR Text Key: 5421241
• Report Number: 1723170-2015-00083
• 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: 12/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 1830617FRT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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