MAUDE Adverse Event Report: SPECTRANETICS CORPORATION PHILIPS LASER SYSTEM; DEVICE, ANGIOPLASTY, LASER, CORONARY

Model Number	LAS-100
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4): device lot, expiration date n/a for this system.H3): the device was evaluated on-site by field service engineer.Inspection found a loose connection to the pulse charging network (pcn), the high voltage circuitry which powers the system.Reconnection was completed, system calibrations were performed, and the system was operating properly.H6): after evaluation, investigation, and repair were complete, a loose connection to the pcn (resulting in a loss of power) was determined to be the cause of the reported failure.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat moderately calcified anterior tibial arteries, discovered to be occluded during the diagnostic portion of the procedure.An atherectomy was necessary to relieve the patient''s pain and symptoms.The patient was on the table, and conscious sedation had been administered.During use, a philips laser system displayed a fault 600, which rendered the system inoperable, and the procedure could not be completed.No other options were available to cross the occlusion, so the procedure was aborted, with plans to reschedule the patient after the laser system was repaired.There was no reported patient harm.This report captures the pls, terminal system failure, potential for harm with recurrence.

• Brand Name: PHILIPS LASER SYSTEM
• Common Device Name: DEVICE, ANGIOPLASTY, LASER, CORONARY
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 18489604
• Report Number: 3007284006-2024-00005
• Device Sequence Number: 12526777
• Product Code: LPC
• UDI-Device Identifier: 00813132027452
• UDI-Public: (01)00813132027452(11)221215
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P910001 S120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2024

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: LAS-100
• Device Catalogue Number: LAS-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER MANUFACTURER/TYPE/SIZE UNK; GUIDE WIRE, MANUFACTURER/TYPE/SIZE UNK; INTRODUCER SHEATH MANUFACTURER/TYPE/SIZE UNK; LASER CATHETER MANUFACTURER/TYPE/SIZE UNK
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic
• Patient Race: White