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

Model Number	110-004
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A3): patient''s gender unk.B6): relevant tests/laboratory data unk.H3): visual inspection found excessive wrinkles on the elca''s outer jacket, spanning 11 mm to the distal tip, with no breaches noted.Distal tip contained two dead fibers, and portions of the epoxy were damaged and missing.At the proximal end, one dead fiber was present, and the beam imprint was not visible.During functional testing, the device calibrated successfully.The damaged epoxy may have caused the calibration failure during preparation for use.However, it could not be determined when or how the damage occurred.H6): based on the device evaluation, the cause of the reported failure could not be established.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 proximal left anterior descending (lad) artery.The patient had been prepped with groin access, angiograms had been taken, and given moderate sedation.A spectranetics elca coronary laser atherectomy catheter could not be calibrated.Two different laser systems were used to attempt calibration with no success; calibration of a new elca was then attempted, but failed as well.The procedure was aborted since no other treatment was available.The groin access required closure and the patient survived, with plans to reschedule the procedure at a later date.This report captures the second elca which would not calibrate after the procedure had begun, requiring intervention (groin closure).

• Brand Name: ELCA CORONARY LASER ATHERECTOMY CATHETER
• Common Device Name: DEVICE, ANGIOPLASTY, LASER, CORONARY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 17172761
• Report Number: 1721279-2023-00101
• Device Sequence Number: 5642419
• Product Code: LPC
• UDI-Device Identifier: 00813132025458
• UDI-Public: (01)00813132025458(17)250111(10)FG022M22A
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2025
• Device Model Number: 110-004
• Device Catalogue Number: 110-004
• Device Lot Number: FG022M22A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• 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: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2022
• 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: SECOND SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS ELCA CORONARY LASER CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Unknown
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White