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	06/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2) patient date of birth - not available from facility.A5) patient ethnicity - not available from facility.H3/h6) the device was not returned; thus no investigation could be completed, and the cause of the reported failure could not be confirmed.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 a right atrial (ra) lead due to cied system/pocket infection.Spectranetics lld lead locking devices (llds) were inserted into each lead to provide traction.During preparation, the spectranetics 14f glidelight laser was plugged into the spectranetics cvx-300 excimer laser system and calibrated.While removing the rv lead, outer jacket damage was observed.A new glidelight was used to complete the procedure with no reported patient harm.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
D4): device serial number populated.D9): the glidelight device was returned to the manufacturer 30jul2025.H3): visual inspection found a kink along the working length, just distal to the bifurcate handle, with multiple breaches, burns, and broken fibers, spanning 15 mm past the bifurcate handle.A second kink was present 105 mm from the distal tip, with melting of the outer jacked, and burnt and broken fibers present.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.Type of investigation code b01 replaced (from b17).Investigation findings code c0706 replaced (from c20).Investigation conclusions code d1102 replaced (from d14).All other codes remain applicable as listed in the initial mdr.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: 22383387
• Report Number: 3007284006-2025-00121
• Device Sequence Number: 7053552
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/05/2025
• 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: BOSTON SCIENTIFIC RV PACING LEAD (MODEL UNK).; RA PACING LEAD (MANUFACTURER, MODEL UNK).; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LLD LEAD LOCKING DEVICE.
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: Asian