MAUDE Adverse Event Report: MEDTRONIC ENT (JACKSONVILLE) BALLOON SEEKER SPHN 6X17MM; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number 1830617SPH

Device Problem Imprecision (1307)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2015

Event Type  malfunction  

Event Description

A medtronic ent representative reported that, while in an ear, nose and throat (ent) procedure, the surgeon alleged an inaccuracy using a frontal balloon.The surgeon performed a successful tracer registration and confirmed accuracy on superficial anatomical landmarks.The surgeon proceeded to accurately navigate the right frontal sinus, then transferred over to the left frontal sinus and immediately deemed being inaccurate.The balloon showed the surgeon navigating the orbital socket rather than the frontal sinus.Noted was that the patient had sat up at one point to blow her nose but stated that the head strap and patient tracker did not move.The straight suction navigated accurately after the inaccurate navigation of the frontal balloon in the left sinus.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

Device lot number, or serial number, not available.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.On 06/12/2015 the medtronic representative reported that during the procedure, and when switching to the maxillary sinuses, the surgeon was inaccurate in the right sinus (tip of balloon showing in the orbital) and accurate in the left; the opposite of the frontal sinuses.Then noted that the sphenoid balloon in the sphenoid sinuses seemed to be accurate.On 07/06/2015 a medtronic representative, following-up at the site, reported the alleged inaccuracy was approximately 5 millimeters.On 07/08/2015 medtronic representative confirmed the suspect balloon seeker was disposed of at the site, by site staff, and will not be returned to manufacturer for analysis.

Manufacturer Narrative

Correction: it was discovered on 27-jan-2016, that an incorrect date was referenced in a previous supplemental 3500a submission.The reported date of 16-aug-2016 was reported incorrectly and should be 16-aug-2015.Statement in previous supplemental 3500a submission should read: ¿on 30-jun-2015, it was noticed that a coding error in mdr submissions from our facility resulted in the maude database incorrectly coding the devices related to our mdr submissions from 25-may-2015 to 16-aug-2015.The decision to wait until the database was corrected was made after consultation with the fda as advised by a consumer safety officer with the information analysis branch, division of post market surveillance, office of surveillance and biometrics.An it solution was implemented on 16-aug-2015.This mdr was submitted to correct the coding error.There is no new information to change the patient information, event description and/or manufacturer narrative that was previously reported.¿.

• Brand Name: BALLOON SEEKER SPHN 6X17MM
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): MEDTRONIC ENT (JACKSONVILLE); 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC ENT (JACKSONVILLE); 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027 ; 7208902338
• MDR Report Key: 4902222
• MDR Text Key: 6021064
• Report Number: 1723170-2015-00829
• 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,company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 07/09/2015,02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 1830617SPH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 07/09/2015
• Distributor Facility Aware Date: 06/12/2015
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 40 YR
• Patient Weight: 54