MAUDE Adverse Event Report: MEDTRONIC ENT 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 11/04/2014

Event Type  malfunction  

Manufacturer Narrative

Patient identifier was not provided by the site.Patient information provided.

Event Description

A medtronic ent representative reported an alleged inaccuracy occurring while in an ear, nose & throat (ent) procedure, using the fusion navigation with the frontal balloon.The surgeon used an endoscope to confirm accuracy of placement and determined it was correct.The surgeon continued and completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Patient information was not made available from the site.A medtronic representative, following-up at the site, reported the suspect balloon seeker was disposed of by the site.No parts will be returned to manufacturer for analysis.A medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.

• Brand Name: BALLOON SEEKER FRNT 6X17MM
• 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: 4295441
• MDR Text Key: 12648689
• Report Number: 1723170-2014-01301
• 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: User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/30/2016
• Device Catalogue Number: 1830617FRT
• Device Lot Number: 0208805020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2014
• 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: 48 YR
• Patient Weight: 68