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

Model Number	500-302
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2) patient date of birth and age ¿ not available from the facility.A4) patient weight - not available from facility.B6/b7) patient information regarding relevant tests/laboratory data or medical history ¿ not available from the facility.H6) based on the device evaluation and investigation, the probable cause of the missing material 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 lead extraction procedure commenced to remove a right ventricular (rv) and right atrial (ra) lead due to cied system/pocket infection.Spectranetics lld lead locking devices were inserted into each lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath on the rv lead, progress stalled and switched to the ra lead; however, encountered the same obstruction.Targeting the rv lead again, further advancement was made but stalled once more.After attempts to clear, and saline flushing proved ineffective, a new 14f glidelight was used.The rv and ra lead were removed successfully.The patient survived the procedure.Upon device evaluation on 11dec2025, visual inspection found a kink on the tail tube with scraping on the outer jacket near the distal tip.Additionally, there were cracked fibers and missing epoxy observed.Using a borescope to image the inner lumen of the glidelight, a large piece of lead insulation was present, blocking the inner lumen approximately 50 mm from the distal tip.This report captures the glidelight with missing material, potential for harm.

• 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: 23970234
• Report Number: 3007284006-2026-00001
• Device Sequence Number: 12723923
• Product Code: MFA
• UDI-Device Identifier: 00813132020330
• UDI-Public: (01)00813132020330(17)260227(10)FGB24B21A
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/05/2026

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: 02/27/2026
• Device Model Number: 500-302
• Device Catalogue Number: 500-302
• Device Lot Number: FGB24B21A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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: RA PACING LEAD (MANUFACTURER, MODEL UNK); RV LEAD (TYPE, MANUFACTURER, MODEL UNK); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD LEAD LOCKING DEVICE
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian