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

Catalog Number	1830617FRT
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.The suspect balloon was discarded on-site, so no part return is expected.A medtronic representative inspected the navigation system on-site.The inaccuracy could not be replicated, although the suspect balloon was not available for analysis.A full navigation system check-out was completed and all tests passed.Full system functionality was confirmed and the system was returned to service.
Event or Problem Description
A medtronic representative reported that during an ear, nose, and throat procedure, the navigation system was inaccurate.It was reported that the inaccuracy was noted after registration, while navigating a balloon.All other instruments were reportedly accurately navigating.The direction and magnitude of the inaccuracy was not provided.The surgeon elected to complete the procedure with the inaccuracy, and it was completed successfully.The patient was not impacted.

• Brand Name: BALLOON SEEKER FRNT 6X17MM
• Common Device Name: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): MEDTRONIC ENT (JACKSONVILLE); 6743 southpoint drive north; jacksonville FL 32216
• MDR Report Key: 6015415
• Report Number: 1723170-2016-02542
• Device Sequence Number: 11003194
• Product Code: LRC
• UDI-Device Identifier: 00643169420441
• UDI-Public: 00643169420441
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K132297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 1830617FRT
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2016
• Initial Report FDA Received Date: 10/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 92