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

Catalog Number 1830717SPH

Device Problem Imprecision (1307)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2014

Event Type  malfunction  

Manufacturer Narrative

Device manufacture date was unavailable as a valid lot number was not provided.Further engineering analysis found that due to the.32mm difference between this complaint sample and a random sample, it was not possible to conclude whether the instrument was bent during or prior to use.A lot history review was not possible as a valid lot number was not provided.There were no further issues reported from the site.

Event Description

A medtronic ent representative reported that, while in an ear, nose & throat (ent) procedure using a navigated balloon, a 5mm inaccuracy was alleged.It was reported that on its side orientation it was off lateral to medial, and straight up orientation it was off superior to inferior.No further details 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.Device manufacturing date is unavailable.Return requested.Medtronic investigation of returned suspect balloon seeker sphn 7x17mm finds that the balloon tool passed an accuracy test, however, failed a second accuracy test.During the peg board test the target error number was unstable but in the expected range.The target max range is 3.0mm.The tool does not appear to be functioning in the same manner as other tools of the same type.Software analysis finds the returned patient exam did fit medtronic protocol, and are unable to observe any other details that would lead to the reported inaccuracy.

• Brand Name: BALLOON SEEKER EM SPHN 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: 4298761
• MDR Text Key: 13229318
• Report Number: 1723170-2014-01304
• 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: 11/07/2014

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 Catalogue Number: 1830717SPH
• Device Lot Number: 700991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2015
• 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 Age: 66 YR
• Patient Weight: 109