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	11/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A3b) patient gender - not available from facility.A4) patient weight - not available from facility.A5) patient ethnicity - not available from facility.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 is 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.
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) and right atrial (ra) lead due to fracture.Spectranetics lld lead locking devices (llds) were inserted into each lead to provide traction.Beginning with a spectranetics 16f glidelight laser sheath on the rv lead, progress was made through the subclavian vein into the superior vena cava (svc).Resistance was encountered in the upper to mid svc, with lead-on-lead binding, and progress stalled.A large drop in the patient¿s blood pressure was noted, glidelight was removed from the patient, and the blood pressure normalized.Then, the glidelight was loaded on to the ra lead, advancing through the subclavian vein and upper svc until resistance was met again.Lasing resumed, and the ra lead was removed.Targeting the rv lead, forward movement was made; however, resistance was encountered in the upper to mid svc once more, but manual advancement continued and reached the distal tip of the lead.Removing the glidelight, the outer sheath was inserted onto the device and loaded on to the rv lead.Progress was made to the distal tip of the lead, with little resistance through the subclavian vein and svc, and the rv lead was removed.Immediately following removal of the lead and glidelight, the patient¿s blood pressure dropped, and rescue efforts began, including sternotomy.A superior vena cava (svc) perforation was discovered and repaired, and the patient survived the procedure.This report captures the 16f glidelight in use when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics device in use during the procedure.

• 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: 23657377
• Report Number: 3007284006-2025-00251
• Device Sequence Number: 20059493
• Product Code: MFA
• UDI-Device Identifier: 00813132020347
• UDI-Public: (01)00813132020347(17)270505(10)0303464735
• 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): 11/26/2025

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: 0303464735
• 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: 11/17/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2025
• 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; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD LEAD LOCKING DEVICES
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Race: White