MAUDE Adverse Event Report: MEDTRONIC ENT BALLOON SEEKER FRNT 7X17MM; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number 1830717FRT

Device Problem Imprecision (1307)

Patient Problem No Patient Involvement (2645)

Event Date 09/23/2014

Event Type  malfunction  

Event Description

A medtronic representative reported that during training, the frontal balloon was navigating inaccurately, approximately 4mm forward.All other instruments were accurate.There was no patient present when this issue was identified.

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Device manufacturing date is unavailable.No parts have been returned to manufacturer for analysis as this is a disposable instrument.

• Brand Name: BALLOON SEEKER FRNT 7X17MM
• 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: judi ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 4191092
• MDR Text Key: 20751780
• Report Number: 1723170-2014-01114
• 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
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 1830717FRT
• Device Lot Number: M726750B587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1