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	10/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A procedure commenced to remove an inferior vena cava (ivc) filter from a jugular approach, due to the filter no longer being needed.The patient was on the table, anesthetized, and intubated.During the procedure, a philips laser system (pls) displayed an error 106, which rendered the system inoperable, and the procedure could not be completed.The decision was made to terminate the case until the laser could be repaired.The patient was extubated, and the devices in use were removed, with no reported patient harm.This report captures the pls terminal system failure, delay of procedure; potential for harm.
Additional Manufacturer Narrative
D4): device lot, expiration date n/a for this system.The pls was evaluated on-site by a field service engineer.Inspection found the system operable, and the failure could not be duplicated.The sensors were calibrated, attenuator zero (positions the attenuator to detect energy), and system characterization (characterizes system data to ensure that the system energy expected matches system energy detected) were performed.Proper system operation was verified.After evaluation, investigation, and system checks were complete, the complaint could not be duplicated.The cause of the reported failure could not be established.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.

• 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: 20511022
• Report Number: 3007284006-2024-00209
• Device Sequence Number: 8559015
• Product Code: LPC
• UDI-Device Identifier: 00813132027452
• UDI-Public: (01)00813132027452(11)231004
• 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): 10/22/2024

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: 10/04/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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: CAVACLEAR LASER SHEATH; IVC FILTER, MANUFACTURER/MODEL UNK
• Patient Sex: Unknown