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 09/24/2014

Event Type  malfunction  

Event Description

A medtronic ent representative reported that, while in a functional endoscopic sinus surgery (fess) the surgeon alleged the balloon dialator was tracking slightly anterior of its actual position.The surgeon had the balloon inside the frontal sinus and was touching bone, however, images showed being slightly inside the bone.No trouble-shooting was performed as the surgeon deemed the inaccuracy was insignificant enough to continue navigating the balloon as intended.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Patient age and weight were not made available from the site.09/29/2014 a medtronic representative, following-up at the site, reported observing a subsequent procedure with the same doctor, navigation was confirmed to be completely normal and the procedure was completed as planned.No further issues have been reported.Suspect part is a single-use device and will not be returned to manufacturer for analysis; discarded by site.

• 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: 4197979
• MDR Text Key: 5151940
• Report Number: 1723170-2014-01123
• 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: 09/24/2014

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: 06/12/2015
• Device Catalogue Number: 1830717FRT
• Device Lot Number: 0208426676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/24/2014
• Initial Date FDA Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2014
• 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