MAUDE Adverse Event Report: SPECTRANETICS CORPORATION GLIDELIGHT LASER SHEATH; DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS

Model Number	500-302
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/02/2025
Type of Reportable Event	Death
Event or Problem Description
A lead extraction procedure commenced to remove two right atrial (ra) and two left ventricular (lv) leads due to fracture.Spectranetics lld lead locking devices (llds) were inserted into each lead to provide traction.While opening of the pocket, one of the ra leads started to come apart, but did not cut to maintain its structure.Beginning with a spectranetics 14f glidelight laser sheath, the two lv leads, and one ra lead were removed successfully.During extraction of the last ra lead, when the glidelight was being used as a mechanical sheath, it was noticed that the tip was bent.However, extraction continued but the lead broke, and the lld, along with a portion of the lead were removed.The glidelight was removed from the body, and the blood pressure dropped.Rescue efforts began, including rescue balloon, sternotomy, and cell saver.After some time, a perforation in the subclavian vein was discovered, which was originally thought to have been in the superior vena cava (svc).The patient was transferred to the operating room, repair was completed, and the patient stabilized; unfortunately, did not survive the procedure.This report captures the glidelight in use when the subclavian perforation occurred, requiring intervention, but resulting in death.There was no alleged malfunction of the glidelight device in use during the procedure.
Additional Manufacturer Narrative
A2) patient date of birth - not available from facility.A3b) patient gender - not available from facility.D4) device serial number - not available from facility.H3) the glidelight was discarded, thus no returned product investigation was performed.H6) perforation of vessels and death are known risks of complication with use of the glidelight device.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: GLIDELIGHT LASER SHEATH
• Common Device Name: DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
• 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: nicole worford ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 22171544
• Report Number: 3007284006-2025-00113
• Device Sequence Number: 20822671
• Product Code: MFA
• UDI-Device Identifier: 00813132020330
• UDI-Public: (01)00813132020330(17)261204(10)0303356093
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P960042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 500-302
• Device Catalogue Number: 500-302
• Device Lot Number: 0303356093
• 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: 06/02/2025
• Initial Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2024
• 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: BOSTON SCIENTIFIC FINELINE RA PACING LEAD; BOSTON SCIENTIFIC LV LEAD (MODEL UNK); LIVANOVA BEFLEX LV LEAD; LIVANOVA BEFLEX RA PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD LEAD LOCKING DEVICES
• Outcome Attributed to Adverse Event: Death; Life Threatening
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White