MAUDE Adverse Event Report: MEDTRONIC ENT (JACKSONVILLE) 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 09/12/2016

Event Type  malfunction  

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 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
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): MEDTRONIC ENT (JACKSONVILLE); 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC ENT (JACKSONVILLE); 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: nicholas mcnabb ; 826 coal creek circle; louisville, CO 80027 ; 7208902439
• MDR Report Key: 6015415
• MDR Text Key: 56987764
• Report Number: 1723170-2016-02542
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 00643169420441
• UDI-Public: 00643169420441
• 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: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 1830617FRT
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 52 YR
• Patient Weight: 92