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	Cardiac Perforation (2513)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead (with one ra and two rv electrodes) due to non-function.A spectranetics lld lead locking device (lld) was inserted into the ra electrode, and cook medical bulldog lead extenders on the rv electrodes to provide traction from the groin.Beginning with a spectranetics 14f glidelight laser sheath and cook medical 11f evolution shortie, progress was made towards the innominate.Switching to a spectranetics 16f glidelight laser sheath, the lead tip was freed from the heart.Advancement was successful to the ra electrode, when the lld and lead insulation came off.Using the 16f glidelight, no further progress could be made; therefore, switched to a cook medical 13f evolution, and the lead was removed.After extraction, the patient¿s blood pressure dropped, and cardiac tamponade was detected, and suspected an ra perforation.Rescue efforts began, including pericardiocentesis, which stabilized the patient, and the patient survived the procedure.This report captures the 16f glidelight device in the area when the perforation occurred, requiring intervention.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.A4) patient weight - not available from facility.B7) other relevant medical history - not available from facility.H3) the glidelight was discarded, thus no returned product investigation was performed.H6) cardiac perforation is a known risk 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: 22048457
• Report Number: 3007284006-2025-00101
• Device Sequence Number: 9095895
• Product Code: MFA
• UDI-Device Identifier: 00813132020347
• UDI-Public: (01)00813132020347(17)250822(10)FGC23H01A
• 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): 05/19/2025

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 Expiration Date: 08/22/2025
• Device Model Number: 500-303
• Device Catalogue Number: 500-303
• Device Lot Number: FGC23H01A
• 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: 04/30/2025
• Initial Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• 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: BIOTRONIK LINOX SMART PROMRI S DX 65/15; COOK MEDICAL 11F EVOLUTION SHORTIE; COOK MEDICAL 13F EVOLUTION; COOK MEDICAL BULLDOG LEAD EXTENDER; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD LEAD LOCKING DEVICE
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian