MAUDE Adverse Event Report: MEDTRONIC XOMED INC. VISUALASE COOLING LASER APPLICATOR SYSTEM; LASER INSTRUMENT, SURGICAL, POWERED

Model Number	9735561
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that, while testing with the thermal therapy system, there was an issue with the disposable cooling catheter system (ccs) kit.It was reported that lesions formed non-uniformly and ablated tissue was one sided as the unit ablated in a 180 degree region instead of 360 degrees around the laser diffusing fiber (ldf).It was reported that tissue testing was being conducted where under smaller ablation times, the ablated tissue was on one side of the ldf and catheter.It was noted that switching ldf's did not restore functionality, leading to the cooling catheter being suspected to be the cause of the issue.It was noted that a 15w laser with 8ml/min flow and 16 seconds of exposure time were being used.There was no patient present when this issue was identified.

• Brand Name: VISUALASE COOLING LASER APPLICATOR SYSTEM
• Common Device Name: LASER INSTRUMENT, SURGICAL, POWERED
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 10471849
• Report Number: 1045254-2020-00387
• Device Sequence Number: 3085651
• Product Code: GEX
• UDI-Device Identifier: 00643169933378
• UDI-Public: 00643169933378
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2020

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 Expiration Date: 01/24/2021
• Device Model Number: 9735561
• Device Catalogue Number: 9735561
• Device Lot Number: 0217005544
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1