MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) VISUALASE COOLED LASER APPLICATOR SYSTEM; POWERED LASER SURGICAL INSTRUMENT

Catalog Number	9735560
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Device manufacturing date is unavailable.Per engineering, this was part of a shelf life study to determine the expiration date for product labeling for up to 3 years.This defect was found during vv testing of a 3 year accelerated aged product and subsequently failed.The corresponding 2 year accelerated aging study met the acceptance criteria of the protocol.As a result product was labeled with a 2 year expiration date.User impact set to low since user is unlikely to recognize slight drip from proximal end of catheter and flow rate within catheter tubing was still acceptable.
Event or Problem Description
A medtronic engineer, reported on behalf of a medtroninc test engineer, that identified a thermal therapy cooling catheter system (ccs) leak after 3 year aged testing.During execution of a thermal therapy system flow test protocol on 3 year accelerated aged ccs 400s, a leak was detected in one (out of 7) of the parts.This was a 0.4mm core fiber 10mm tip.However, this part still passed the flow rate criteria of this test.The leak was minor and occurred between the proximal end of the catheter tubing and the hub.There was no patient present when this issue was identified.
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: VISUALASE COOLED LASER APPLICATOR SYSTEM
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6425318
• Report Number: 1723170-2017-01250
• Device Sequence Number: 18970392
• Product Code: GEX
• UDI-Device Identifier: 00643169611993
• UDI-Public: 00643169611993
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K053087
• 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
• Report Date (Section B): 05/01/2017

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: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 9735560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2017
• Supplement Report FDA Received Date: 05/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1