MAUDE Adverse Event Report: SPECTRANETICS CORPORATION GLIDELIGHT LASER SHEATH; DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS

Model Number	500-301
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	03/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4) device serial number - not available from facility.H3) the glidelight was discarded, thus no product investigation was performed.H6) the device was discarded; therefore, the cause of the glidelight becoming stuck could not be established.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) lead due to non-function.A right atrial (ra) lead was present within the patient but was not targeted for extraction.A cook medical liberator locking stylet was inserted into the lead to provide traction.Beginning with a spectranetics 12f glidelight laser sheath, advancement was made to the proximal coil of the lead, and stalled.However, when attempting to retract the device, it became stuck and with traction applied to the glidelight, the patient¿s blood pressure dropped and a pericardial effusion was noted.Utilizing a snare, attempts to remove the glidelight were unsuccessful, and the pericardial effusion was growing.Rescue efforts began, including sternotomy, and an rv perforation was discovered and repaired.The glidelight was removed, and the rv lead was extracted using a cook medical byrd dilator sheath post-sternotomy.The patient survived the procedure.This report captures the 12f glidelight in use in the area when the entrapment and perforation occurred, requiring intervention.

• 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: 24735858
• Report Number: 3007284006-2026-00109
• Device Sequence Number: 9242103
• Product Code: MFA
• UDI-Device Identifier: 00813132020323
• UDI-Public: (01)00813132020323(17)270729(10)0303536478
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/30/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 500-301
• Device Catalogue Number: 500-301
• Device Lot Number: 0303536478
• 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: 03/08/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2025
• 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: COOK MEDICAL BYRD DILATOR SHEATH.; COOK MEDICAL LIBERATOR LOCKING STYLET.; RF45D RA PACING LEAD (MANUFACTURER UNK).; RF46D RV PACING LEAD (MANUFACTURER UNK).; SNARE (MANUFACTURER UNK).; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian