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 Codes	Great Vessel Perforation (2152); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	09/10/2026
Type of Reportable Event	Death
Event or Problem Description
A lead extraction procedure commenced to remove two right ventricular (rv) (left and right side) and two right atrial (ra) leads (left and right side) due to bacteremia.Spectranetics lld lead locking devices (llds) was inserted into each lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath on the left rv lead, adhesions in the vasculature were removed.Switching to a spectranetics 13f tightrail sub-c rotating dilator sheath, the left rv and left ra lead were removed successfully.Next, a spectranetics 16f glidelight laser sheath was used on both the right rv and right ra.When lasing on the right rv lead, the patient's blood pressure dropped and a pericardial effusion was detected via transesophageal echocardiogram (tee).Rescue efforts began, including rescue balloon, cpr, and sternotomy.A perforation at the inferior vena cava (ivc)/ra junction into the ra was discovered and repaired; however the patient did not survive procedure, and the right ra and rv lead remained in the patient.This report captures the 16f glidelight in use when the perforation occurred, requiring intervention, but resulting death.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
B7) other relevant history - not available from facility.D4) device serial number - not available from facility.H3) the glidelight was discarded, thus no product investigation was performed.H6) per ifu, perforation and death are listed as potential adverse events 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: 50803939
• Report Number: 3007284006-2026-00451
• Device Sequence Number: 8653048
• Product Code: MFA
• UDI-Device Identifier: 00813132020347
• UDI-Public: (01)00813132020347(17)271106(10)0303626205
• 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): 09/17/2026

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: 0303626205
• 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: 09/13/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2025
• 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: Medtronic 5076 RA pacing lead.; Medtronic 5076 RV pacing lead.; 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 Lead Locking Devices.
• Outcome Attributed to Adverse Event: Life Threatening; Death
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 123 LB
• Patient Race: White