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 Code	Unintended Radiation Exposure (4565)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A coronary atherectomy procedure commenced to treat moderately calcified, chronic total occlusion (cto) in the proximal left anterior descending (lad) artery.A spectranetics elca coronary laser atherectomy catheter was used to treat the patient.After the atherectomy was completed, the elca got caught on the 7f guide catheter, and both the guide catheter and elca were removed as a system.Upon removal, it was observed that the elca exit wire port was damaged.The procedure was completed with no reported patient harm.Upon completion of the elca device evaluation and investigation on 19sep2024, a breach in the outer jacket was detected, with visible fibers present in the area of the breach.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
B7): other relevant history unk h3): the elca was returned for evaluation.Visual inspection found the rx port pulled away from the inner lumen, with a visible breach in the outer jacket.The outer jacket is twisted and wrinkled in the area of the breach.Fibers are visible in the area of the damage, but no broken fibers were detected.H6): based on completion of the device evaluation and investigation, this has been determined to be a use related failure.Historically, the manufacturer has seen this failure during manipulation of the device, when the guide wire is pulled laterally away from the port, resulting in 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.

• 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: 20322266
• Report Number: 3007284006-2024-00198
• Device Sequence Number: 18144107
• Product Code: LPC
• UDI-Device Identifier: 00813132025458
• UDI-Public: (01)00813132025458(17)250502(10)FG023D19A
• 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): 09/27/2024

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: 05/02/2025
• Device Model Number: 110-004
• Device Catalogue Number: 110-004
• Device Lot Number: FG023D19A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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: ASAHI ASTATO 0.014 GUIDE WIRE; BOSTON SCIENTIFIC 7F GUIDE CATHETER; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TERUMO 7F INTRODUCER SHEATH
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 105 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White