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

Model Number	LAS-100
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2: patient date of birth: not available from facility.B7: other relevant medical history: not available from facility.H3: the pls was evaluated on-site by a field service engineer.During inspection, it was noted that the optics and spotsize were misaligned.The settings were adjusted, calibrated, and verified with an elca catheter with no issues.The system met specifications and was returned to service.H6: after evaluation, misalignment of the optics and spotsize 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 coronary atherectomy procedure commenced to treat the patient, necessitating the use of a philips laser system (pls) to power a spectranetics elca coronary laser atherectomy catheter.During the procedure, 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: 21516664
• Report Number: 3007284006-2025-00040
• Device Sequence Number: 18569923
• Product Code: LPC
• UDI-Device Identifier: 00813132027452
• UDI-Public: (01)00813132027452(11)221027
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2025

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: 02/19/2025
• Initial Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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 WIRE (SIZE, MANUFACTURER UNK); INTRODUCER SHEATH (SIZE, MANUFACTURER UNK); SPECTRANETICS ELCA LASER CATHETER
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White