MAUDE Adverse Event Report: MEDTRONIC ENT BALLOON SEEKER FRNT 6X17MM; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number 1830617FRT EM

Device Problem Imprecision (1307)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2014

Event Type  malfunction  

Manufacturer Narrative

Expiration date provided.Manufacture date provided.The device was returned to the manufacturer for analysis.In the software application the balloon tool passed instrument verification.A reference was placed on the tip of the nose of the phantom head model with a pen mark.The registration probe was placed on the pen mark and the location was noted in ent.That same pen mark was used as a reference for the balloon tool.The instrument showed normal tracking in the software and on the model.The tool passed the pegboard test for accuracy.The device was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.Corrected to initial use of device.

Event Description

A medtronic ent representative reported that, while in an ear, nose & throat (ent) procedure, the site trialed a nuvent frontal balloon for the first time, using it with a navigation system.The site alleged a 2-3mm tracking inaccuracy from the patient scan, noting that all other instruments and shaver blades were tracking normally.The surgeon was unable to use the balloon to dilate the frontal sinus and opted to use a different product to continue the procedure.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Patient information was unavailable from the site.Device manufacturing date is unavailable.A medtronic representative, following-up at the site, reported the doctor stated that this patient presented challenging frontal anatomy, especially on the right side.A "skewed frontal recess", it wasn't a "straight forward anatomical approach" but was difficult.The same doctor used nuvent on two other cases the same day with no issues.No parts have been returned to manufacturer for analysis.

• 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: 4032599
• MDR Text Key: 12371439
• Report Number: 1723170-2014-00887
• 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: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/22/2015
• Device Catalogue Number: 1830617FRT EM
• Device Lot Number: 0208482921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1