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

Model Number	500-302
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Great Vessel Perforation (2152); Pericardial Effusion (3271)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4) device serial number- not provided by facility.H3) the 14f glidelight was discarded, thus no returned product investigation was performed.H6) great vessel 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.
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) lead due to non-function.A right ventricular (rv) lead was present in the patient but was not targeted for extraction.A spectranetics lld ez lead locking device (lld ez) was inserted into the ra lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath on the ra lead, progress was achieved to about an inch from the tip of the lead, when the patient¿s blood pressure dropped.A pericardial effusion was detected, and rescue efforts began, including rescue balloon, and sternotomy.An svc perforation was discovered and repaired.The ra lead was removed post-sternotomy, and the patient survived the procedure.This report captures the 14f glidelight in use when the perforation occurred, 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: 21858519
• Report Number: 3007284006-2025-00073
• Device Sequence Number: 20807914
• Product Code: MFA
• UDI-Device Identifier: 00813132020330
• UDI-Public: (01)00813132020330(17)261125(10)0303350050
• 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): 04/16/2025

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: 500-302
• Device Catalogue Number: 500-302
• Device Lot Number: 0303350050
• 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: 04/07/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2024
• 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: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LLD EZ LEAD LOCKING DEVICE.; ST. JUDE MEDICAL 2088 RA PACING LEAD.; ST. JUDE MEDICAL 7122 RV ICD LEAD.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White