MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. MALLEABLE SUCTION MEDIUM, STANDARD TIP; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number 9735016

Device Problems Bent (1059); Suction Problem (2170); Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2014

Event Type  malfunction  

Event Description

A medtronic representative reported that, while in a procedure, a site's malleable suction lost tracking functionality after it was bent 90 degrees at approximately 1 centimeter from the instrument tip.The instrument had been used throughout the procedure without issue.The surgeon opted to continue navigation and there was no issue or delay.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.Returned suspect malleable suction is under analysis.Results not yet available.

Manufacturer Narrative

On (b)(6) 2015, malleable suction was received by the manufacturer for analysis.On 01/14/2015, the medtronic investigation of returned suspect device was completed and found that the suction tool shows red status and will not navigate.Coil # 1 is showing a high resistance, coil #1-20m ohms, coil #2-350 ohms, coil #3-350 ohms.The reported event was confirmed to be caused by a electrical failure.

Manufacturer Narrative

Further engineering analysis found that the cause of resistance in coil# 1 was unable to be determined.Per initial evaluation performed on 1/14/15, the instrument would not verify and displayed "red status" when hooked up to the axiem controller due to an electrical issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

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: MALLEABLE SUCTION MEDIUM, STANDARD TIP
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 4403824
• MDR Text Key: 18630917
• Report Number: 1723170-2015-00018
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133665
• 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,Followup,Followup
• Report Date: 06/17/2015,02/22/2016

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 Catalogue Number: 9735016
• Device Lot Number: 140530J
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/09/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 06/17/2015
• Distributor Facility Aware Date: 05/21/2015
• Initial Date Manufacturer Received: 05/21/2015
• Initial Date FDA Received: 01/09/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/29/2015; 06/17/2015; 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2014
• 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: 61 YR
• Patient Weight: 89