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

Catalog Number	9733068
Medical Device Problem Codes	Communication or Transmission Problem (2896); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).On 01/05/2016 a medtronic representative, following-up at the site, confirmed the surgeon did not attempt to take a sample with the damaged needle.Return requested for suspect biopsy needle.Medtronic investigation of returned suspect device finds that the biopsy needle was received with blood contamination.As reported, the sphere assembly is no longer solidly attached to the biopsy needle.The spheres can be moved up and down the needle changing the geometry of the instrument.Pieces loose - physical damage.
Event or Problem Description
A medtronic representative reported that while in a cranial biopsy procedure, the surgeon alleged that the biopsy needle was damaged and the spheres moved.The surgeon was inserting the biopsy needle and used "excessive" force to insert the needle.At that time the spheres moved and it indicated the biopsy needle was farther than it actually was in the software.A new biopsy needle was brought in to be used in continuing the procedure.The surgeon obtained a positive sample with the new biopsy needle.Delay in therapy was 10 minutes.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.
Additional Manufacturer Narrative
The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: BIOPSY NEEDLE KIT, PASSIVE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6252072
• Report Number: 1723170-2017-00145
• Device Sequence Number: 829055
• Product Code: HAW
• UDI-Device Identifier: 00643169546820
• UDI-Public: 00643169546820
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K971247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2017

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
• Operator of Device: Physician
• Device Expiration Date: 08/09/2018
• Device Catalogue Number: 9733068
• Device Lot Number: 066522216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/16/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 02/14/2017; 04/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 79