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

Model Number	500-301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	06/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A3b) patient gender - 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 returned product investigation was performed.H6) per ifu, pericardial effusion is listed as a possible 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.
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.Utilizing multiple spectranetics devices (12f glidelight laser sheath, 14f glidelight laser sheath, 16f glidelight laser sheath, 11f tightrail sub-c rotating dilator sheath, and 13f tightrail sub-c rotating dilator sheath) the rv and ra leads were removed.Post-extraction, the initial transesophageal echocardiogram (tee) was negative for an effusion; however, several minutes later after a repeat tee, a small pericardial effusion was detected.Under continued monitoring, it was noted that the pericardial effusion had grown, and rescue efforts began, including pericardiocentesis.The patient survived the procedure.This report captures the 12f glidelight in use when a pericardial effusion occurred post-procedure, requiring intervention.There was no alleged malfunction of the glidelight 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: 25588088
• Report Number: 3007284006-2026-00376
• Device Sequence Number: 12175341
• Product Code: MFA
• UDI-Device Identifier: 00813132020323
• UDI-Public: (01)00813132020323(17)270106(10)0303372964
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2026

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: 500-301
• Device Catalogue Number: 500-301
• Device Lot Number: 0303372964
• 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: 06/11/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2025
• 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: ABBOTT 1948 RV PACING LEAD.; ABBOTT 2088TC RA PACING LEAD.; PHILIPS LASER SYSTEM.; SPECTRANETICS 11F TIGHTRAIL SUB-C DILATOR SHEATH.; SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH.; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH.; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH.; SPECTRANETICS LLD LEAD LOCKING DEVICES.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Hispanic
• Patient Race: White