MAUDE Adverse Event Report: MONTERIS MEDICAL SIDEFIRE DIRECTIONAL LASER PROBE; SIDEFIRE¿ DIRECTIONAL LASER PROBE

Catalog Number	NBP-000-01
Medical Device Problem Codes	Fracture (1260); Insufficient Heating (1287)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the probe was inspected and noted to be attached to the laser pilot light; red light was observed near the depth stop.The fiber was broken, and the fiber break was described as a high-stress fracture, as the fiber in the break area was shattered.Oily substance was found on the outside of the polyimide layer of the fiber near the break which appeared to be excess uncured ultraviolet adhesive.
Event or Problem Description
It was reported that during an ablation procedure, upon checking the laser tip prior to inserting the probe, the light looked dim.The clinical specialist then inspected the umbilicals and noted red laser light was visibly noticeable close to the white and yellow depth lock.There were no patient complications reported in relation to this event.

• Brand Name: SIDEFIRE DIRECTIONAL LASER PROBE
• Common Device Name: SIDEFIRE¿ DIRECTIONAL LASER PROBE
• Manufacturer (Section D): MONTERIS MEDICAL; 14755 27th ave n; suite c; plymouth MN 55447
• MDR Report Key: 8046516
• Report Number: 3009970070-2018-00086
• Device Sequence Number: 1585432
• Product Code: GEX
• UDI-Device Identifier: 00816589020816
• UDI-Public: 00816589020816
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K131278
• 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): 11/07/2018

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: 04/02/2020
• Device Catalogue Number: NBP-000-01
• Device Lot Number: 41042-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1