MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. MALLEABLE SUCTION MEDIUM, ANGLE TIP; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9735017

Device Problem Device Sensing Problem (2917)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2014

Event Type  malfunction  

Event Description

A medtronic representative reported that the angled medium malleable suction stopped tracking during an ear, nose & throat (ent) procedure.The instrument was bent three times during the procedure.The system could track all other instruments without issue and it was thought that they had metal in the field.This caused no delay in surgery or impact to the outcome of the patient.

Manufacturer Narrative

Patient identifier was unavailable from the site.The device was returned to the manufacturer for analysis.The tool shows red status with error "poor signal" in the system accuracy test.The suction tool would not navigate.Diagnostics in the cranial application showed only 2 coils sending data.Pins 1-2 measured as open.Pins 3-4 measured 350 ohms.Pins 7-8 measured 346 ohms.The reported event was confirmed.This was a demo product and the account team did not need a replacement.

Manufacturer Narrative

Further engineering evaluation completed on 9/16/2014 found the suction was bent in the no-bend area showing a kinked area in the stainless steel tube.The center coil tests disconnected.The 58 gage coil wire is likely broken at the solder joint.It is very difficult to see the 58 gage wires even under 3x mag.

• Brand Name: MALLEABLE SUCTION MEDIUM, ANGLE TIP
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer Contact: catherine eaton ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902092
• MDR Report Key: 4013162
• MDR Text Key: 17282263
• Report Number: 1723170-2014-00859
• 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: User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 07/18/2014

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: 9735017
• Device Lot Number: 140423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/16/2014
• Initial Date FDA Received: 08/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2014
• 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: 24 YR
• Patient Weight: 68