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

Model Number	114-009
Medical Device Problem Codes	Off-Label Use (1494); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A coronary atherectomy procedure commenced to treat a plaque lesion in the mid right coronary artery (rca).A spectranetics elca coronary laser atherectomy catheter completed several runs in the artery with no issues.However, the decision was made to lase in contrast (off-label use), and during the last run, the distal marker band separated within the patient.A snare was used to attempt retrieval of the marker band, but unsuccessful.The tip was far down in the vessel, and no further attempts to remove were made.The procedure was completed with no reported patient harm.This report captures the elca distal marker band which separated, requiring intervention, but retained in patient.
Additional Manufacturer Narrative
A2) patient date of birth and age - not available from facility.A4) patient weight - not available from facility.A5) patient ethnicity - not available from facility.A6) patient race - not available from facility.B7) other relevant history, including preexisting medical conditions - not available from facility.H3) the device was not returned, thus no findings were available.H6) the elca was used in an off-label manner (lasing in contrast).The ifu states, "flush all residual contrast media from the lasing site and vascular structures adjacent to the lasing site, prior to activating the laser system." 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: 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: 22018310
• Report Number: 3007284006-2025-00096
• Device Sequence Number: 15823566
• Product Code: LPC
• UDI-Device Identifier: 00813132025441
• UDI-Public: (01)00813132025441(17)250612(10)FH123E25A
• 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): 05/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2025
• Device Model Number: 114-009
• Device Catalogue Number: 114-009
• Device Lot Number: FH123E25A
• 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: 04/25/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2023
• 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: ASAHI 0.014 SION BLUE GUIDE WIRE.; CORDIS 6F GUIDE CATHETER.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; TERUMO 6F INTRODUCER SHEATH.
• Patient Sex: Male