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

Model Number	LAS-100
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2-a6) patient information - not available from facility.B6/b7) patient information regarding relevant tests/laboratory data or medical history - not available from facility.G3) late report captured under philips igtd capa event 397.H3) the pls was evaluated on-site by a field service engineer.During inspection, it was noted that the prism that relects a portion of light to the prism energy sensor (pes) was defective.The prism was replaced, the system was calibrated, and verified proper system operation.The system met specifications and was returned to service.H6) after evaluation, the defective prism 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 procedure commenced to treat a patient, necessitating the use of a philips laser system (pls).During use, the pls displayed an error 106, which rendered the system inoperable, and the procedure could not be completed.The procedure was postponed until the system could be repaired, delaying treatment of the patient.There was no reported patient harm.This report captures the pls terminal system failure, delay of procedure; potential for harm.

• 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: nicole worford ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 24593776
• Report Number: 3007284006-2026-00078
• Device Sequence Number: 10391774
• Product Code: LPC
• UDI-Device Identifier: 00813132027452
• UDI-Public: (01)00813132027452(10)0303446783
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P910001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

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: 11/19/2025
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2025
• 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: SPECTRANETICS LASER ATHERECTOMY DEVICE (TYPE UNK)
• Patient Sex: Unknown