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	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A lead extraction procedure commenced, and a spectranetics 14f glidelight laser sheath and a spectranetics visisheath dilator sheath were being used to treat the patient.Upon loading the glidelight device onto a spectranetics lld lead locking device (lld), damaged was noted near the handle of the device.A new glidelight was used to complete the procedure with no reported patient harm.Upon completion of the glidelight device evaluation on 10apr2025, visual inspection found a kink on the working length of the device, just distal to the bifurcate handle.At the area of the kink, a breach was detected on the outer jacket, with melting and broken fibers.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
B6/b7) patient information regarding relevant tests/laboratory data or medical history - not available from facility.H3/h6) based on the device evaluation and investigation, this has been determined to be a use related failure.Historically, the manufacturer has seen this failure when the force required to advance and maneuver is greater than the force that the working length can accommodate.When these forces are applied to the side of the outer jacket, at or near the bifurcate handle, the device becomes kinked.Broken fibers in the 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: 21861568
• Report Number: 3007284006-2025-00076
• Device Sequence Number: 11910509
• Product Code: MFA
• UDI-Device Identifier: 00813132020330
• UDI-Public: (01)00813132020330(17)261125
• 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): 04/17/2025

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 Model Number: 500-302
• Device Catalogue Number: 500-302
• Device Lot Number: 0303350050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD LEAD LOCKING DEVICE; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Sex: Unknown