MAUDE Adverse Event Report: Spectranetics Corporation GlideLight Laser Sheath; Device, Removal, Pacemaker Electrode, Percutaneous

Model Number	500-303
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) and right atrial (ra) leads due to non-function.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath on both leads, significant adhesions were encountered.Switching to a spectranetics 13f tightrail sub-c rotating dilator sheath, advancement was made through the subclavian region.Next, utilizing the 14f glidelight, progress remained challenging due to the extensive adhesions and lead on lead binding.Upsizing to a spectranetics 16f glidelight laser sheath, gradual advancement was made to the distal coil of the rv lead.With traction from the lld ez, the rv lead was removed; however, the patient's blood pressure dropped and rescue efforts began, inlcuding cpr, pericardiocentisis, and sternotomy.An rv perforation was discovered, and repaired, and the ra lead was removed post-sternotomy.The patient survived the procedure.This report captures the glidelight in use when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
B2) due to failed submission for entering 2 outcomes, adding here the additional outcomes attributed to adverse event: life threatening.B6/b7) patient information regarding relevant tests/laboratory data or medical history - 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) per ifu, perforation is listed as a potential adverse event with use of glidelight devices.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 ; +1(719)447-2465
• MDR Report Key: 50221178
• Report Number: 3007284006-2026-00417
• Device Sequence Number: 10315960
• Product Code: MFA
• UDI-Device Identifier: 00813132020347
• UDI-Public: (01)00813132020347(17)271118(10)0303632118
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/11/2026

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: 500-303
• Device Catalogue Number: 500-303
• Device Lot Number: 0303632118
• 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: 07/24/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2025
• 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 pacing lead (manufacturer, model UNK).; Spectranetics 13F TightRail Sub-C Dilator Sheath.; Spectranetics 14F GlideLight Laser Sheath.; Spectranetics CVX-300 Excimer Laser System.; Spectranetics LLD EZ Lead Locking Devices.
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 156 LB
• Patient Race: White