MAUDE Adverse Event Report: MEDTRONIC ENT BALLOON SEEKER 1830517SPH EM SPHN 5X17MM; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number 1830517SPH

Device Problem Imprecision (1307)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2014

Event Type  malfunction  

Event Description

A medtronic ent representative reported that, while in an ear, nose & throat (ent) procedure, the surgeon alleged a 3mm inaccuracy in the posterior direction with the sphenoid navigated balloon when actively opening the sinus.The surgeon deemed being accurate with both the straight suction and malleable suction instruments.In trouble-shooting, the surgeon used the straight suction to confirm location with the balloon.It was determined they were accurate in both the superior and inferior directions, however, the balloon was showing 3mm posterior to the actual location.The surgeon opted to continue to navigate.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

This is a disposable device and will not be returned to manufacturer for analysis.A medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.A medtronic representative, following-up at the site, reported that since the reported event, this site has completed successful procedures using this type of device without further issue.

• Brand Name: BALLOON SEEKER 1830517SPH EM SPHN 5X17MM
• 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: judi ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 4265390
• MDR Text Key: 5007938
• Report Number: 1723170-2014-01254
• 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: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/19/2016
• Device Catalogue Number: 1830517SPH
• Device Lot Number: 0208574934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2014
• 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: 50 YR
• Patient Weight: 116