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

Model Number	110-004
Medical Device Problem Codes	Material Separation (1562); Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A): the patient's date of birth, age at time of event, sex, gender, weight, ethnicity, and race are unknown.B6/b7): patient information regarding relevant tests/laboratory data or medical history are unknown.G3): the elca device was returned for evaluation and was decontaminated 16oct2024.H3): visual inspection found missing epoxy and broken fibers (resulting in sharp edges) at the elca distal tip.H6): based on the device evaluation and investigation, this event has been determined to be use related.Inadequate flushing technique and patient condition (severely calcified target lesion) likely resulted in a lack of hydration at the treatment site, causing the damage observed.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 distal circumflex artery.A spectranetics elca coronary laser atherectomy catheter was used to treat the patient.During the procedure, the distal tip of the catheter appeared damaged, and use of the device was discontinued.Another 0.9mm catheter was used to successfully complete the procedure with no reported patient harm.Upon device evaluation 17oct2024, missing material and sharp edges were discovered at the elca distal tip.This report captures the elca with missing material and sharp edges at the distal tip, potential for harm.

• 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: 20511149
• Report Number: 3007284006-2024-00210
• Device Sequence Number: 7203523
• Product Code: LPC
• UDI-Device Identifier: 00813132025458
• UDI-Public: (01)00813132025458(17)251016(10)FG023J20A
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2024

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 Expiration Date: 10/16/2025
• Device Model Number: 110-004
• Device Catalogue Number: 110-004
• Device Lot Number: FG023J20A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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: EBU 3.75 6F GUIDE CATHETER, MANUFACTURER UNK; GUIDE WIRE, MANUFACTURER/SIZE UNK; PHILIPS LASER SYSTEM
• Patient Sex: Unknown