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

Model Number	110-004
Medical Device Problem Codes	Off-Label Use (1494); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2) patient date of birth ¿ not available from the facility.A3) patient sex - not available from facility.A5) patient ethnicity - not available from facility.B6) relevant tests/laboratory data ¿ not available from the facility.H6) based on the device evaluation and investigation, it is suspected that the patient condition/target lesion being a cto contributed to the difficulty of hydration reaching the treatment site.The lack of hydration resulted in the damage to the distal tip of the device.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 a lesion in the right coronary artery.A spectranetics elca coronary laser atherectomy catheter was used to treat the patient via radial access (off-label use).During use, the catheter could not be recognized after insertion and failed to calibrate.Another catheter was used to complete the procedure with no reported patient harm.Upon device evaluation on 29may2025, visual inspection found the inner lumen was deformed inward, and there was missing and broken epoxy, with chipped fibers at the elca distal tip.This report captures the elca with missing material, potential for harm.

• 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: 22318195
• Report Number: 3007284006-2025-00117
• Device Sequence Number: 8830451
• Product Code: LPC
• UDI-Device Identifier: 00813132025458
• UDI-Public: (01)00813132025458(17)250403(10)FG023C21D
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/24/2025

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 Expiration Date: 04/03/2025
• Device Model Number: 110-004
• Device Catalogue Number: 110-004
• Device Lot Number: FG023C21D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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: MEDTRONIC 6F GUIDE CATHETER; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TERUMO 0.018 GUIDE WIRE; TERUMO 6F INTRODUCER SHEATH
• Patient Age: 53 YR
• Patient Sex: Unknown
• Patient Weight: 65 KG
• Patient Race: Asian