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

Model Number	114-009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2): patient's date of birth, age unk a4): patient's weight unk b6): relevant tests/laboratory data unk d4): device serial number unk 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 severely calcified lesion in the mid right coronary artery (rca).A spectranetics elca coronary laser atherectomy catheter was used to treat the patient.During lasing, a perforation was noted in the rca.Rescue efforts began immediately, with medications being used to stabilize the patient's blood pressure.Then, two papyrus stents were placed to seal the perforation, and the procedure was completed.The patient survived, and 48 hours post-procedure, was doing well.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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 19619928
• Report Number: 3007284006-2024-00134
• Device Sequence Number: 15083166
• Product Code: LPC
• UDI-Device Identifier: 00813132025441
• UDI-Public: (01)00813132025441(17)251127(10)FH123L13A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P910001 S118
• 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): 06/26/2024

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 Expiration Date: 11/27/2025
• Device Model Number: 114-009
• Device Catalogue Number: 114-009
• Device Lot Number: FH123L13A
• 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: 06/04/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2023
• 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: ABBOTT 0.014 WIGGLE GUIDE WIRE; BOSTON SCIENTIFIC 6F GUIDE CATHETER; CORDIS 6F AVANTIA INTRODUCER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American