MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. VMAX NAV 4.0MM TAP (CANNULATED); NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9733182

Device Problems Partial Blockage (1065); Complete Blockage (1094)

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2014

Event Type  malfunction  

Event Description

A medtronic representative reported that a cannulated tap instrument was clogged; a guide wire could not pass through the instrument.There was no patient present when this issue was identified.

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Replacement device shipped to site for issue resolution.No parts have been received by the manufacturer for analysis.

Manufacturer Narrative

The returned tap is new and unbent.The guide wire passes through without issue.No problem found.

• Brand Name: VMAX NAV 4.0MM TAP (CANNULATED)
• 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: 4423597
• MDR Text Key: 5277211
• Report Number: 1723170-2015-00047
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 9733182
• Device Lot Number: 140716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1