MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9735602

Device Problem Imprecision (1307)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2018

Event Type  malfunction  

Manufacturer Narrative

Unknown patient age at the time of the event.No parts have been returned for analysis at this time.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system.It was reported that there was an alleged inaccuracy during a fess procedure.The site was using two different navigation systems for the case.They first used an acclarent navigation system for their balloons, then swapped to the 2nd navigation system to navigate their shaver.When they were ballooning, the ct scan showed their balloon right on the edge of the eye.They then swapped for the 2nd navigation system and registered the patient on the 2nd navigation system.When they put their probe into that sinus, the 2nd navigation system showed the probe in the eye by a few mm.They re-registered the patient, confirmed accuracy again after registration, and they still showed the probe a few mm into the eye.They were not physically present in the eye, but the location showed in software was where the eye showed on the ct scan.It appeared as if the balloon had "pushed" the eye laterally.There was no delay to the procedure.

Manufacturer Narrative

Correction to the 510k number.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The software investigation found that they were unable to determine the probable cause without further information since the on-going investigation proved to be inconclusive.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system.It was reported that there was an alleged inaccuracy during a fess procedure.The site was using two different navigation systems for the case.They first used an accelerant navigation system for their balloons, then swapped to the 2nd navigation system to navigate their shaver.When they were ballooning, the ct scan showed their balloon right on the edge of the eye.They then swapped for the 2nd navigation system and registered the patient on the 2nd navigation system.When they put their probe into that sinus, the 2nd navigation system showed the probe in the eye by a few mm.They re-registered the patient, confirmed accuracy again after registration, and they still showed the probe a few mm into the eye.They were not physically present in the eye, but the location showed in software was where the eye showed on the ct scan.It appeared as if the balloon had "pushed" the eye laterally.There was no delay to the procedure.

• Brand Name: FUSION
• Type of Device: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central ave ne; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7951709
• MDR Text Key: 123396331
• Report Number: 1723170-2018-05049
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2019

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
• Device Operator: Health Professional
• Device Model Number: 9735602
• Device Catalogue Number: 9735602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 09/11/2018; 12/13/2018
• Supplement Dates FDA Received: 10/18/2018; 01/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Weight: 82