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 Codes	Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3/h6: the elca device was not returned for evaluation, thus no returned 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 to treat a severely calcified lesion in the mid right coronary artery (rca).A spectranetics elca laser atherectomy catheter, along with a 0.014 guidewire (manufacturer unknown), terumo 6f introducer sheath, and a cordis 6f guide catheter, were used to treat the patient.During use, laser light was observed emitting near the plug.The elca was removed and a new elca was used to complete the procedure with no reported patient harm.This report is being submitted due to unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
D4) device serial number added.H3) the elca was returned to the manufacturer for evaluation.Visual inspection found the tail tube and working length in good condition with no breaches to the outer jacket.Red laser light was visible near the coupler; however, this is considered normal.At the distal tip, multiple broken fibers and missing epoxy was observed.H6) based on the device evaluation and investigation, it is suspected that the patient condition/target lesion 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.Component code g04129 replaced (from g04037, g04053).Type of investigation code b01 replaced (from b17).Investigation findings code c070603 replaced (from c20).Investigation conclusions code d1001 replaced (from d14).All other codes are applicable as listed in the initial mdr.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: 24586029
• Report Number: 3007284006-2026-00083
• Device Sequence Number: 20256089
• Product Code: LPC
• UDI-Device Identifier: 00813132025458
• UDI-Public: (01)00813132025458(17)271020(10)0303606233
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P910001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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: 0303606233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2025
• 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: 0.014 GUIDEWIRE (MANUFACTURER UNK); CORDIS 6F GUIDE CATHETER; PHILIPS LASER SYSTEM; TERUMO 6F INTRODUCER SHEATH
• Patient Sex: Male
• Patient Weight: 90 KG