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	03/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A3b) patient gender - not available from facility.A5) patient ethnicity - not available from facility.A6) patient race - 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) 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 ventricular (rv), right atrial (ra), and left ventricular (lv) lead due to chronic pain.A spectranetics lld ez lead locking device (lld ez) was inserted into the ra lead to provide traction.First, a non-philips shockwave device was used in the innominate and superior vena cava (svc) area.Then, using a spectranetics 14f glidelight laser sheath and a spectranetics visisheath dilator sheath on the ra lead, advancement was made to the svc with some difficulty.The glidelight was removed, and the lv lead was being prepped when the patient¿s blood pressure dropped.An effusion was detected via transesophageal echocardiogram (tee), and rescue efforts began, including bypass and sternotomy.An svc perforation was discovered and repaired.The rv, ra, and lv leads were removed post-sternotomy.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 any spectranetics 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: 21721819
• Report Number: 3007284006-2025-00054
• Device Sequence Number: 9414418
• Product Code: MFA
• UDI-Device Identifier: 00813132020330
• UDI-Public: (01)00813132020330(17)260724(10)FGB24G15A
• 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): 03/28/2025

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: 07/24/2026
• Device Model Number: 500-302
• Device Catalogue Number: 500-302
• Device Lot Number: FGB24G15A
• 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: 03/14/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2024
• 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: MEDTRONIC 4592 LV LEAD; MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 6935 RV ICD LEAD; PHILIPS LASER SYSTEM; SHOCKWAVE DEVICE; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 70 KG