MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC VISUALASE LASER GUIDED ABLATION SYSTEM; LASER INSTRUMENT, SURGICAL, POWERED

Model Number	002-1100
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.Other relevant device(s) are: vlas 9735660 10mm tip/1.65mm catheter.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that, while in a soft neuro tissue ablation procedure, the lure lock on the cooling catheter would not tighten.The malfunction resulted in the lure lock rotating freely.There was no reported delay to the procedure due to this issue.There was no reported impact on patient outcome.

• Brand Name: VISUALASE LASER GUIDED ABLATION SYSTEM
• Common Device Name: LASER INSTRUMENT, SURGICAL, POWERED
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8655964
• Report Number: 1723170-2019-02800
• Device Sequence Number: 19394831
• Product Code: GEX
• UDI-Device Identifier: 00643169584440
• UDI-Public: 00643169584440
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2019

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: Health Professional
• Device Model Number: 002-1100
• Device Catalogue Number: 002-1100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 97