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

Model Number	500-302
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Pericardial Effusion (3271)
Date of Event	08/07/2026
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 lead locking devices (llds) were inserted into each lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath on the ra lead, progress stalled due to calcium or patient anatomy.Adding a spectranetics visisheath dilator sheath, the laser jumped forward slightly and the ra lead was removed.However, a pericardial effusion was detected and rescue efforts began, including sternotomy.An innominate perforation was discovered and repaired, and the rv 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
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: 50329261
• Report Number: 3007284006-2026-00422
• Device Sequence Number: 12139474
• Product Code: MFA
• UDI-Device Identifier: 00813132020330
• UDI-Public: (01)00813132020330(17)280604(10)0303765800
• 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): 08/19/2026

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: 500-302
• Device Catalogue Number: 500-302
• Device Lot Number: 0303765800
• 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: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2026
• 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: Abbott 1642T RA pacing lead; Abbott 1646T RV pacing lead; Philips Laser System; Spectranetics LLD Lead Locking Devices; Spectranetics VisiSheath Dilator Sheath
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 120 LB
• Patient Race: White