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

Catalog Number 1830717FRT

Device Problem Imprecision (1307)

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

Event Date 12/05/2014

Event Type  malfunction  

Manufacturer Narrative

The software investigation found that the reported event was unrelated to a software issue.A review of the scan used for patient registration found that the patient was not scanned to protocol as the ears and the top of the head were missing.The software functioned as designed.

Event Description

A medtronic representative reported that during a functional endoscopic sinus surgery (fess) the surgeon alleged the navigated balloon instrument was inaccurate.The surgeon stated it was accurate on the right side of the patient's anatomy, but not the left.The surgeon completed the procedure with the use of the navigation system.It was reported that the surgeon inflated the balloon in the wrong part of the patient's anatomy.There was no reported damage to the sinus of the patient.The surgeon reported that the patient was recovering from the surgery and doing fine.

Manufacturer Narrative

Patient weight was not available from the site.Device manufacture date was unavailable as a valid lot number was not provided.Replacement device shipped to site for issue resolution.On (b)(4) 2014, a medtronic representative went to the site to test the equipment.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The device was returned to the manufacturer for analysis.The balloon seeker was connected to a test system and navigation was normal.It was disconnected and reconnected multiple times with no trouble found.The device remained in green tracking status for a 24 hour burn-in test.The device passed the accuracy test and was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The most likely cause was user technique during clinical use.

Manufacturer Narrative

Additional information: patient weight provided.

• 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; 6743 southpoint drive; louisville CO 80027 9710
• Manufacturer Contact: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 4372044
• MDR Text Key: 12893176
• Report Number: 1723170-2014-01424
• 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,company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 1830717FRT
• Device Lot Number: M726750B587 D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 42 YR
• Patient Weight: 104