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	Perforation of Vessels (2135); Great Vessel Perforation (2152)
Date of Event	03/04/2026
Type of Reportable Event	Death
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra), two right ventricular (rv) leads, and a left ventricular (lv) lead due to cied system/pocket infection.Spectranetics lld lead locking devices (llds) were inserted into each lead to provide traction.Using a spectranetics 16f glidelight laser sheath, all the leads were removed.Following the procedure, the patient was transferred to the intensive care unit; however, the patient's blood pressure dropped.Rescue efforts began, including sternotomy.A superior vena cava (svc)/innominate junction perforation was discovered, but repair attempts were unsuccessful.The patient did not survive the procedure.This report captures the 16f glidelight used in the procedure when a perforation occurred, requiring intervention, but resulting in death.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
A3b) patient gender - not available from the facility.A4) patient weight - not available from facility.A5/a6) patient ethnicity and race - not available from facility.B6/b7) patient information regarding relevant tests/laboratory data or medical history - not available from facility.H3) the glidelight was discarded, thus no product investigation was performed.H6) per ifu, perforation and death are listed as a potential adverse event with use of the glidelight device.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: 24690347
• Report Number: 3007284006-2026-00103
• Device Sequence Number: 9855232
• Product Code: MFA
• UDI-Device Identifier: 00813132020347
• UDI-Public: (01)00813132020347(17)270721(10)0303530141
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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: 0303530141
• 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: 03/04/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2025
• 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: PHILIPS LASER SYSTEM; SPECTRANETICS LLD LEAD LOCKING DEVICES; ST. JUDE MEDICAL 1258T LV LEAD; ST. JUDE MEDICAL 1688TC RA PACING LEAD; ST. JUDE MEDICAL 1688TC RV PACING LEAD; ST. JUDE MEDICAL 7121 RV PACING LEAD
• Outcome Attributed to Adverse Event: Death; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Female