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); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect biopsy needle was returned to the manufacturer for analysis.The needle was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.
Event or Problem Description
A medtronic representative reported that, while in a cranial biopsy, the biopsy needle would not track when placed within the reducing tube of the biopsy set.The site opened another biopsy needle and were able to track the instrument without issue.No additional information was provided.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.

• 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: 6503545
• Report Number: 1723170-2017-01669
• Device Sequence Number: 231839
• Product Code: HAW
• UDI-Device Identifier: 00643169546820
• UDI-Public: 00643169546820
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,user f
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 04/19/2017

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: 09/20/2018
• Device Catalogue Number: 9733068
• Device Lot Number: 066526416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2017
• Initial Report FDA Received Date: 04/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 83