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	Unintended Radiation Exposure (4565)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead, due to bi-ventricular upgrade.There was a right atrial (ra) lead present within the patient but was not initially targeted for extraction.A spectranetics lld lead locking device (lld) was inserted into the lead to provide traction.Beginning with a spectranetics 14f glidelight device on the rv lead, lead on lead binding with the ra lead was encountered, and the ra lead started pulling back.At that time, the rv lead broke, and the remaining portion of the lead and lld were removed from the patient.The ra lead was then pulled out with manual traction, and the glidelight was removed from the body.However, upon removal, a kink and red laser light emitting was observed.Continuing the procedure, femoral snare was attempted to remove the remaining portion of the rv lead but was unsuccessful.The decision was made to abandon the rv lead; therefore, the lead was capped and remained in the patient.The patient survived the procedure.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
H3) the glidelight device was returned for evaluation.Visual inspection found kinks and twisting along the working length, with three breaches to the outer jacket, melting, and broken fibers spanning 255 mm from the distal tip.H6) based on the device evaluation and investigation, this has been determined to be a use related failure.The device interaction with lead on lead binding likely resulted in additional forces being applied to the outside of the jacket, resulting in the kinking and broken fibers.Broken fibers in the damaged area redirect the laser energy, which creates a breach in the outer jacket.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: 23621891
• Report Number: 3007284006-2025-00250
• Device Sequence Number: 21090523
• Product Code: MFA
• UDI-Device Identifier: 00813132020330
• UDI-Public: (01)00813132020330(17)260730(10)FGB24G18A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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: 07/30/2026
• Device Model Number: 500-302
• Device Catalogue Number: 500-302
• Device Lot Number: FGB24G18A
• 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: 10/29/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• 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 7741 RA PACING LEAD; BOSTON SCIENTIFIC 7742 RV PACING LEAD; PHILIPS LASER SYSTEM; SPECTRANETICS LLD LEAD LOCKING DEVICE
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White