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 Tamponade (2226); Cardiac Perforation (2513)
Date of Event	02/27/2026
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) lead due to non-function.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath on the ra lead, progression was slow, so attention shifted to the rv lead.However, advancement remained challenging; therefore, a spectranetics 13f tightrail rotating dilator sheath was utilized, and reached the upper superior vena cava (svc).Concern for an obstruction in the svc, a spectranetics 16f glidelight laser sheath was deployed through the suspected occlusion, with minimal progress, due to the lead firmly embedded in the vessel wall and surrounded by extensive calcification.During further advancement, the patient¿s blood pressure dropped, cardiac tamponade was detected via transoesophageal echocardiography (tee), and rescue efforts began, including sternotomy.An svc/ra junction perforation was discovered and repaired, and the leads were removed post-sternotomy.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 the spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
A2) patient date of birth - not available from facility.A3b) patient gender - not available from 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.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.

• 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: 24595963
• Report Number: 3007284006-2026-00081
• Device Sequence Number: 8985635
• Product Code: MFA
• UDI-Device Identifier: 00813132020347
• UDI-Public: (01)00813132020347(17)270211(10)0303402520
• 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): 03/12/2026

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: 0303402520
• 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: 02/27/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2025
• 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 5034 RA PACING LEAD; MEDTRONIC 5534 RV PACING LEAD; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 44 YR
• Patient Sex: Female