MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS ELCA CORONARY 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	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A coronary atherectomy procedure commenced to treat a lesion in the patient's proximal left anterior descending (lad) artery.A spectranetics elca coronary atherectomy catheter was selected to treat the patient.The elca calibrated successfully, but during use in the patient an "error 3" code was displayed.The procedure was completed using a new catheter and the patient survived the procedure with no reported patient harm.During the product return evaluation, a breach in the outer jacket was discovered.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
A2): patient's date of birth, age unk.A3): patient's gender unk.A4): patient's weight unk.A5a./5b.): patient's ethnicity/race unk.B6): relevant tests/laboratory data unk.H3) the elca device was returned and evaluated by a cross-functional team.Wrinkles were observed in the tail tube extending 15mm proximal from the distal tip.Charring was noted at the distal tip and a breach was detected in the outer jacket at the distal fuse.Three dead fibers were visible at the distal tip and at the proximal end (per specifications, a maximum of 2 dead fibers are allowed).There was no design or manufacturing issue identified, and the elca passed laser test and established qc checks before release, confirming the dead fibers occurred after distribution.The elca could not be tested for calibration due to the breach in the outer jacket.H6): it is unknown when or how the device damage occurred; therefore, the cause of the device damage 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.

• Brand Name: SPECTRANETICS ELCA CORONARY 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: 16765639
• Report Number: 1721279-2023-00058
• Device Sequence Number: 6182453
• 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 S117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/18/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• 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: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: GUIDE CATHETER MANUFACTURER/SIZE UNK; GUIDE WIRE MANUFACTURER/SIZE UNK; INTRODUCER SHEATH MANUFACTURER/SIZE UNK; SECOND SPECTRANETICS ELCA LASER CATHETER; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Sex: Unknown