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	Great Vessel Perforation (2152)
Date of Event	05/29/2025
Type of Reportable Event	Death
Event or Problem Description
A lead extraction procedure commenced to remove two right ventricular (rv), a right atrial (ra), and a left ventricular (lv) lead due to cied system/pocket infection, redundant lead, and occlusion.Spectranetics lld lead locking device (llds) were inserted into each lead to provide traction.Beginning with a spectranetics 16f glidelight laser sheath, the ra, lv, and one rv lead were removed.During extraction of the last rv lead, the glidelight device perforated the superior vena cava (svc) and rescue efforts began, including sternotomy.The perforation was repaired; however, the svc wall had become very thin, and there was difficulty in repairing.The patient was transferred to icu, but unfortunately did not survive the procedure.This report captures the 16f glidelight device in use when the 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
A2) patient date of birth - not available from facility.A5) patient ethnicity - 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) great vessel perforation and death are known risks of complication 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: 22345996
• Report Number: 3007284006-2025-00120
• Device Sequence Number: 8527484
• Product Code: MFA
• UDI-Device Identifier: 00813132020347
• UDI-Public: (01)00813132020347(17)261011(10)303309205
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 06/27/2025

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: 0303309205
• 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: 06/02/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2024
• 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: LV LEAD (MANUFACTURER, MODEL, TYPE UNK); PHILIPS LASER SYSTEM; RA LEAD (MANUFACTURER, MODEL, TYPE UNK); RV LEAD (MANUFACTURER, MODEL, TYPE UNK); SPECTRANETICS LLD LEAD LOCKING DEVICES; ST. JUDE MEDICAL RV ICD LEAD (MODEL UNK)
• Outcome Attributed to Adverse Event: Death; Life Threatening
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Race: Asian