MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. BALLOON SEEKER FRNT 7X17MM

Catalog Number 1830717FRT

Device Problem Imprecision (1307)

Patient Problems Cerebrospinal Fluid Leakage (1772); Iatrogenic Source (2498)

Event Date 10/06/2014

Event Type  Injury  

Event Description

A medtronic ent representative reported that, while in a functional endoscopic sinus surgery (fess), the surgeon noted an inaccuracy with their 7mm balloon seeker, alleging the navigated device caused a cerebrospinal fluid (csf) leak in the patient that would require repair.All other instrumentation was accurate at this time.The surgeon completed the procedure with the use of the navigation system.

Manufacturer Narrative

Patient weight not made available from the site.Device lot number, or serial number, not available.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.(b)(4) 2014.A medtronic representative performed a navigation system check-out, software & hardware areas passed.System performed as intended.(b)(4) 2014: a medtronic representative, following-up at the site, reported that the surgeon stated that following the reported procedure, the patient was doing fine and experiencing no issues from the csf leak.No parts have been returned to manufacturer for analysis.

Manufacturer Narrative

A medtronic site representative reported that the amount of the inaccuracy was unknown and not determined.The surgeon usually verified the instrument by touching the patient's nose before proceeding with navigating the instrument.The emitter was placed at the proper distance and there were no tracking issues during the procedure.It was unlikely that there was metal interference with the emitter.It was possible that there was head strap movement during surgery and the surgeon did re-register the patient during the procedure.Engineering evaluation found that no further investigation was possible as the device was not returned for analysis.The most likely cause was head strap movement due to operator technique.

• Brand Name: BALLOON SEEKER FRNT 7X17MM
• Type of Device: BALLOON SEEKER FRNT 7X17MM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 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: 4226464
• MDR Text Key: 4996478
• Report Number: 1723170-2014-01182
• 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: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 1830717FRT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 64 YR