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

Catalog Number	9733068
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial report occurred on (b)(6) 2016 and was found to be a non-reportable malfunction based on the information available at the time the event occurred.On 01/17/2017, a retrospective review related to a capa was completed for all events where the reported malfunction was not previously associated with serious injuries; the reporting determination has been revised to consider these malfunction events reportable.No parts have been received by the manufacturer for evaluation.A replacement biopsy needle was shipped to the site.Part was discarded by the site.
Event or Problem Description
A medtronic representative, following up with the site, reported that the biopsy needle was difficult to slide in and out during biopsy collection.The screw on the reducing tube was tightened too far which caused the issue moving the biopsy needle.The case was completed using the biopsy needle.Immediately after the case, the site discarded the biopsy needle.There was no reported delay to the procedure 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: 6326902
• Report Number: 1723170-2017-00614
• Device Sequence Number: 1081422
• 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
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 02/13/2017

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: 02/12/2017
• Device Catalogue Number: 9733068
• Device Lot Number: 066504315
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2017
• Initial Report FDA Received Date: 02/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 73