MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) BALLOON SEEKER FRNT 6X17MM; INSTRUMENT, ENT MANUAL SURGICAL

Model Number FUSION

Device Problem Imprecision (1307)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

On 09/12/2016 a medtronic representative performed a navigation system check-out, software and hardware areas passed.Instruments test failed.The site doctor stated that the balloon did not navigate accurately.All other instruments were accurate, however, the balloon was not used during that surgery, issue resolved.System performed as intended.No parts were replaced.No parts have been received by manufacturer for analysis.No further issues have been reported.

Event Description

A medtronic representative reported that, while in an ear, nose & throat (ent) procedure, the surgeon alleged an inaccuracy issue with balloon.The surgeon could not tell when and how much of the inaccuracy.No further details regarding this issue, or specifically when it occurred, were provided.The surgeon did state that this instrument was not used after inaccuracy was detected.The surgeon opted to continue and completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.

Manufacturer Narrative

Correction.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts have been received by manufacturer for analysis.

• Brand Name: BALLOON SEEKER FRNT 6X17MM
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 6012400
• MDR Text Key: 56969574
• Report Number: 1723170-2016-02502
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 00613994380005
• UDI-Public: 00613994380005
• 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,Followup
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FUSION
• Device Catalogue Number: 1830617FRT
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2014
• 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