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

Model Number	110-004
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2): patient age and dob is unk a3a): patient sex is unk a3b): patient gender is unk a4): patient weight is unk b6/b7): patient information regarding relevant tests/laboratory data or medical history are unk.D9/g3): the elca device was returned on 07jan2025 and evaluated on 10jan2025.H3): visual inspection found missing fibers, missing epoxy, and charring at the distal tip, resulting in sharp edges.During functional testing, the elca was connected to a laboratory cvx-300 system, calibrated successfully and ran at high energy.H6): based on the device evaluation, the reported complaint of an error message could not be replicated.Additionally, the probable cause of the damaged distal tip 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.
Event or Problem Description
A coronary atherectomy procedure commenced to treat a plaque in the right coronary artery (rca).A spectranetics elca coronary laser atherectomy catheter was used to treat the patient.During use, the catheter gave an error two to three seconds after laser exposure.A new catheter was used to complete the procedure.No patient injury reported.Upon completion of the elca device evaluation on 10jan2025, visual inspection found sharp edges at the distal tip.This report captures the elca with sharp edges at the distal tip, 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: 21269037
• Report Number: 3007284006-2025-00023
• Device Sequence Number: 3531469
• Product Code: LPC
• UDI-Device Identifier: 00813132025458
• UDI-Public: (01)00813132025458(17)251205(10)FG023L27A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/29/2025

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: 12/05/2025
• Device Model Number: 110-004
• Device Catalogue Number: 110-004
• Device Lot Number: FG023L27A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• 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 GUIDE WIRE; ASAHI: 6F GUIDE CATHETER; SPECTRANETICS CVX-300 LASER SYSTEM; TERUMO: 6F INTRODUCER SHEATH
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian