MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) BIOPSY NEEDLE KIT, PASSIVE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9733068

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2016

Event Type  malfunction  

Manufacturer Narrative

Device expiration date unavailable.Device manufacturing date unavailable.Investigation of returned suspect biopsy needle finds that the needle insert is also bent causing difficulty during insertion, it is not possible to determine when or how the needle became bent.Using the cranial app and the resin head exam, the biopsy needle was able to track without issue.Rotating the needle to expose all sides of the reflective spheres had no adverse effect.The reported issue was confirmed to be caused by physical damage.

Event Description

A medtronic representative reported that during a cranial biopsy the surgeon felt the inner cannula of the biopsy needle felt "tight" while removing the sample.The surgeon opted to complete the procedure without the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Correction to device unique device identifier (udi) now provided.Device expiration date now provided.Device manufacturing date now provided.

• Brand Name: BIOPSY NEEDLE KIT, PASSIVE
• Type of Device: NEUROLOGICAL 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027 ; 7208902338
• MDR Report Key: 6126584
• MDR Text Key: 60877063
• Report Number: 1723170-2016-05555
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169702943
• UDI-Public: 00643169702943
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/21/2018
• Device Catalogue Number: 9733068
• Device Lot Number: 066511216A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2016
• 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: 68 YR
• Patient Weight: 66