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 Codes	Great Vessel Perforation (2152); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	08/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A3b) patient gender - 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 and cardiac perforation are known risks 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 bacteremia.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath and spectranetics visisheath dilator sheath, the lv lead was removed successfully.Next, upsizing to a spectranetics 16f glidelight laser sheath, the rv lead was removed without issue.Then, attempting removal of the ra lead, the lead started to unravel; therefore, the decision was made to snare from the groin.Using multiple non-philips devices (agilis nxt steerable introducer, boston scientific bard ep catheter, and medtronic spiderfx wire) and the 16f glidelight along with the visisheath, all were advanced with some resistance, but able to reach the tip of the lead.With traction from the snare, the lead released; however, the blood pressure dropped.A pericardial effusion was not initially evident via transesophageal echocardiogram (tee), but became apparent from a different view.Rescue efforts began, including pericardiocentesis, which was unsuccessful, and sternotomy was performed.An svc/ra junction perforation was discovered and repaired, and the patient survived the procedure.This report captures the 16f glidelight in use when the perforation occurred, requiring intervention.There was no alleged malfunction of the spectranetics devices 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: 23080549
• Report Number: 3007284006-2025-00179
• Device Sequence Number: 4785711
• Product Code: MFA
• UDI-Device Identifier: 00813132020347
• UDI-Public: (01)00813132020347(17)270710(10)0303521273
• 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): 09/17/2025

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: 500-303
• Device Catalogue Number: 500-303
• Device Lot Number: 0303521273
• 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: 08/29/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2025
• 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: AGILIS NXT STEERABLE INTRODUCER; BOSTON SCIENTIFIC BARD EP CATHETER; MEDTRONIC SPIDERFX WIRE; PHILIPS LASER SYSTEM; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White