MAUDE Adverse Event Report: Spectranetics Corporation Philips Laser System; Device, Angioplasty, Laser, Coronary

Model Number	LAS-100
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction

• 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 ; +1(719)447-2465
• MDR Report Key: 50796536
• Report Number: 3007284006-2026-00446
• Device Sequence Number: 10571479
• Product Code: LPC
• UDI-Device Identifier: 00813132027452
• UDI-Public: (01)00813132027452(11)260623
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 08/24/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2026
• 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
• Patient Sex: Unknown