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

Catalog Number 1830717FRT

Device Problem Imprecision (1307)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2014

Event Type  malfunction  

Event Description

A medtronic ent representative reported that, while in an ear, nose & throat (ent) procedure, the site alleged that when using a frontal balloon, in the software the tip appeared to be much deeper than it actually was in the patient.No specific measurements of the alleged inaccuracy, or further details of the procedure, were provided.There was no impact on patient outcome.

Manufacturer Narrative

Device lot number, or serial number, not available.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.A medtronic representative, following-up, reported the alleged inaccuracy was approximately 2mm off into the anterior bone of the frontal sinus.(b)(4) 2014 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.No parts have been returned to manufacturer for analysis.

Manufacturer Narrative

Correction to procode provided.Expiration date, lot number and associated manufacture date 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; louisville CO 80027 971
• Manufacturer Contact: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 4139579
• MDR Text Key: 4914360
• Report Number: 1723170-2014-01043
• 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: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/25/2016
• Device Catalogue Number: 1830717FRT
• Device Lot Number: 0208593334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2014
• Initial Date FDA Received: 10/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2014
• 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: 25 YR
• Patient Weight: 93