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

Model Number	110-004
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A coronary atherectomy procedure commenced to treat a lesion in the left anterior descending coronary artery.A spectranetics ecla laser atherectomy catheter was being calibrated; however, calibration was unsuccessful.The procedure was completed without the use of the elca, with no reported patient harm.During evaluation on 19feb2026, visual inspection found a breach/puncture to the working length, with a broken fiber visible.Melting of the outer jacket was observed 86 mm from the distal tip.Calibration was not possible due to the breach at the working length.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
A2) patient date of birth - not available from facility.A3b) patient gender - not available from facility.A5) patient ethnicity - not available from facility.B6/b7) patient information regarding relevant tests/laboratory data or medical history - not available from facility.H6) based on the device evaluation and investigation, the cause of the reported failure and damage 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: 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: 24645863
• Report Number: 3007284006-2026-00084
• Device Sequence Number: 21334230
• Product Code: LPC
• UDI-Device Identifier: 00813132025458
• UDI-Public: (01)00813132025458(17)270915(10)0303575443
• 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): 03/19/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: PHILIPS LASER SYSTEM
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Race: Asian