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

Catalog Number 9735016

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

A replacement malleable suction was sent to the site for issue resolution.The suspect malleable suction was received back for evaluation on 12/09/2015.Findings as follows: the malleable suction tool shows red status with error "poor signal" in the system accuracy test.The suction tool will not navigate.1 of 3 coils is open: coil #1 pins 1-2 measures as 361.3 ohms.Coil #2 pins 3-4 measures 363.0 ohms.Coil #3 pins 7-8 measures as open.This issue will be trended and monitored in a medtronic hardware anomaly tracking database.

Event Description

A medtronic field representative reported that they were unable to track the medium-standard malleable suction (pn: 9735016/ ln: 150108a).He stated that they were initially able to track, but then it stopped tracking during navigation.He confirmed no metal in the field to cause interference, but he adjusted the electromagnetic emitter to see if it would pick the instrument up.Manipulating the emitter did not resolve the issue.The rep got another disposable malleable suction and plugged it into the axiem box.It was able to track it without issue.No delay to case and no negative impact on the patient outcome due to reported event.

• Brand Name: MALLEABLE SUCTION MEDIUM, STANDARD TIP
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: catherine eaton ; 826 coal creek circle; louisville, CO 80027 ; 7208902092
• MDR Report Key: 5300464
• MDR Text Key: 34138421
• Report Number: 1723170-2015-01552
• 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,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/15/2015

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: 150108A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Weight: 60