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	05/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A coronary atherectomy procedure commenced to treat a severely calcified lesion in the distal left anterior descending artery (lad).A spectranetics elca coronary laser atherectomy catheter was used to treat the patient.After lasing 8 times successfully, an attempt was made to lase for the 9th time, when the surgeon had a feeling of electrical leakage.An abrasion in the epidermal layer of the catheter was noted, and use of the device was discontinued.Some of the contrast media in the coronary arteries remained, and the procedure was completed with no reported patient harm.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
H3/h6): the device was not returned, thus no investigation could be completed, and the reported complaint could not be confirmed.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: jill jacoby ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 17733285
• Report Number: 3007284006-2023-00022
• Device Sequence Number: 18080078
• Product Code: LPC
• UDI-Device Identifier: 00813132025458
• UDI-Public: (01)00813132025458(17)240615(10)FG022F03A
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P910001 S118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/12/2023

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: 06/15/2024
• Device Model Number: 110-004
• Device Catalogue Number: 110-004
• Device Lot Number: FG022F03A
• 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: Not provided
• Initial Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2022
• 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 SION GUIDE WIRE SIZE UNK; MEDTRONIC EBU3.5 7F GUIDE CATHETER; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TERUMO RS*A60G16SQZ INTRODUCER SHEATH SIZE UNK
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 68 KG