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

Catalog Number 1830517FRT

Device Problem Imprecision (1307)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2014

Event Type  malfunction  

Event Description

A medtronic ent representative reported that, while in a ear, nose & throat (ent) procedure, there was an inaccuracy with a balloon seeker.The surgeon was accurate on the surface, however, inaccurate laterally to the left in the sinus.Re-registering the patient did not resolve the issue.The surgeon opted to continue and completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Patient age was approximated, not available from the site.Suspect balloon seeker is a disposable device and was discarded at the site; no investigation will be possible.

Manufacturer Narrative

The software investigation found that the root cause was unable to be determined without further information since the on-going investigation proved to be inconclusive based on the information provided.A medtronic representative reported that there have been no further issues reported.A subsequent surgery was completed successfully.

• Brand Name: BALLOON SEEKER EM FRNT 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 4327478
• MDR Text Key: 5254189
• Report Number: 1723170-2014-01349
• 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,Followup
• Report Date: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/12/2016
• Device Catalogue Number: 1830517FRT
• Device Lot Number: 0208548898
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2014
• 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
• Patient Age: 40 YR
• Patient Weight: 82