MAUDE Adverse Event Report: SPECTRANETICS CORPORATION ELCA CORONARY LASER ATHERECTOMY CATHETER; DEVICE, ANGIOPLASTY, LASER, CORONARY

Model Number	110-004
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
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.D4) device serial number - not available from facility.H3/h6) the elca device was discarded, thus no product investigation was performed.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 using a spectranetics elca laser atherectomy catheter to treat the patient.During advancement to the lesion, the catheter became stuck on a non-philips guidewire; therefore, removed as a system.A new catheter was used to complete the procedure with no reported patient harm.This report is being submitted due to removal as a system.There is potential for harm if it were to recur.

• Brand Name: ELCA CORONARY LASER ATHERECTOMY CATHETER
• 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: 23537737
• Report Number: 3007284006-2025-00238
• Device Sequence Number: 10186678
• Product Code: LPC
• UDI-Device Identifier: 00813132025458
• UDI-Public: (01)00813132025458(17)270915(10)0303575443
• 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): 11/12/2025

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: 110-004
• Device Catalogue Number: 110-004
• Device Lot Number: 0303575443
• 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: 10/23/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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, SIZE UNK); GUIDEWIRE (MANUFACTURER, SIZE UNK); INTRODUCER SHEATH (MANUFACTURER, SIZE UNK); PHILIPS LASER SYSTEM
• Patient Sex: Unknown