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

Model Number	110-004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	03/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A3b) patient gender - not available from facility.A6) patient race - not available from facility.D4) device serial number - not available from the facility.H3) the device was discarded, thus no device evaluation could be completed.H6) perforation of vessels is a known risk of complication with use of the elca 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 plaque lesion in the left anterior descending (lad) artery.Multiple devices (spectranetics elca coronary laser atherectomy catheter, philips omniwire pressure guide wire, philips eagle eye platinum ivus catheter, philips angiosculpt scoring balloon catheter, terumo 0.014 runthrough guidewire, terumo 6f introducer sheath, and medtronic 6f guide catheter) were used to treat the patient.During use of the elca catheter, a perforation was noted in the lad.Rescue efforts began immediately, including an abbott graftmaster coronary stent graft system, a balloon to seal the perforation, and surgical treatment.The patient survived the procedure.This report captures the elca in use when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• 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: 21861246
• Report Number: 3007284006-2025-00075
• Device Sequence Number: 12723082
• Product Code: LPC
• UDI-Device Identifier: 00813132025458
• UDI-Public: (01)00813132025458(17)270117(10)0303384816
• 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): 04/17/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 110-004
• Device Catalogue Number: 110-004
• Device Lot Number: 0303384816
• 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: 03/24/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2025
• 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: MEDTRONIC 6F GUIDE CATHETER.; PHILIPS ANGIOSCULPT SCORING BALLOON CATHETER.; PHILIPS EAGLE EYE PLATINUM IVUS CATHETER.; PHILIPS LASER SYSTEM.; PHILIPS OMNIWIRE PRESSURE GUIDE WIRE.; TERUMO 6F INTRODUCER SHEATH.; TERUMO RUNTHROUGH 0.014 GUIDE WIRE.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic