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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2) patient age and date of birth - not available from the facility.A4) patient weight - not available from the facility.A5) patient ethnicity - not available from the facility.A6) patient race - not available from the facility.B6/b7) patient information regarding relevant tests/laboratory data or medical history - not available from the 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 in stent restenosis in the left anterior descending (lad) artery.A spectranetics elca coronary laser atherectomy catheter and a non-philips rotablator were used to treat the patient.After multiple runs, a perforation was noted in the lad.Rescue efforts began immediately, including a covered stent to seal the perforation, and the procedure was completed.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.
Additional Manufacturer Narrative
B5) additional information provided by the philips rep stated the elca was lasing in contrast when the perforation occurred.H6) the elca was used in an off-label manner (lasing in contrast).The ifu states, "flush all residual contrast media from the lasing site and vascular structures adjacent to the lasing site, prior to activating the laser system." all other codes in the initial mdr remain applicable.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 in stent restenosis in the left anterior descending (lad) artery.A spectranetics elca coronary laser atherectomy catheter and a non-philips rotablator were used to treat the patient.After multiple runs while lasing in contrast (off-label use), a perforation was noted in the lad.Rescue efforts began immediately, including a covered stent to seal the perforation, and the procedure was completed.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.
Event or Problem Description
This adverse event is no longer reportable because the perforation was not due to the elca device; rather it was a wire from a different manufacturer.
Additional Manufacturer Narrative
B5/h1/h6) based on new information received, this has been determined as no longer reportable.The perforation was not due to the elca device; rather it was a wire from a different manufacturer.Although the philips rep used the device off-label, this did not cause or contribute to the perforation.Therefore, the following codes were updated: medical device problem code a2304- "off-label use" is no longer applicable.Investigation findings code updated from c23- "usage problem identified" to c20- "no findings available".Revert back to initial mdr code.Investigation conclusion code updated from d1103- "cause traced to intentional off-label, unapproved, or contraindicated use" to d20- "cause traced to another 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.

• 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: 21576971
• Report Number: 3007284006-2025-00043
• Device Sequence Number: 8225945
• Product Code: LPC
• UDI-Device Identifier: 00813132025458
• UDI-Public: (01)00813132025458(17)261206(10)0303356877
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2025

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: 0303356877
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 05/09/2025; 05/16/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/15/2025; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2024
• 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: GUIDE CATHETER (SIZE, MANUFACTURER UNK).; GUIDE WIRE (SIZE, MANUFACTURER UNK).; INTRODUCER SHEATH (SIZE, MANUFACTURER UNK).; PHILIPS LASER SYSTEM.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Male