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 11/06/2014

Event Type  malfunction  

Event Description

A medtronic ent representative reported that, while in an ear, nose & throat (ent) procedure, the site alleged an inaccuracy with the navigated balloon.It was noted that it showed on the anterior side of the bone, instead of the posterior side.No further details, or specific measurement, were provided.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Patient identifier not made available from the site.A medtronic representative, following-up at the site, reported that the balloon tip showed being in the sinus and then it showed on the other side of the bone of the sinus, not accurate.The sinus was a frontal sinus.No parts have been returned to manufacturer for analysis.

Manufacturer Narrative

A medtronic representative reported that the actual instrument used during the reported event had been discarded and was unavailable for evaluation.The medtronic representative went to the site to test the rest of the navigation equipment.The hardware, software, and instrumentation passed the system checkout.The system was found to be fully functional.The reported event was unable to be replicated by medtronic personnel.

• 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: 4298821
• MDR Text Key: 5059149
• Report Number: 1723170-2014-01305
• 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: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• 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: 208593334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: 60 YR
• Patient Weight: 68