MAUDE Adverse Event Report: SPECTRANETICS CORPORATION LLD EZ LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number	518-062
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A3b) patient gender - not available from facility.H3) lld was discarded, thus no product investigation was performed.H6) per ifu, perforation is listed as a potential adverse event with use of the lld 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 bacteremia and endocarditis.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Utilizing multiple spectranetics devices (11f tightrail sub-c rotating dilator sheath, 11f tightrail rotating dilator sheath (long), 14f glidelight laser sheath, 13f tightrail rotating dilator sheath (long), 12f glidelight laser sheath, 16f glidelight laser sheath, and visisheath (large and small) dilator sheaths), the ra lead was successfully removed.Targeting the rv lead with the 13f tightrail rotating dilator sheath (long), it would not advance past the midway point between the two coils of the lead due to extruding wires from the lead.During the attempt to bend the extruding wires back toward the distal tip which would free advancement of the tightrail, the distal tip released from the rv apex freewall.The rv lead was removed; however, the patient¿s blood pressure dropped, and a pericardial effusion detected via transesophageal echocardiogram (tee).Rescue efforts began, including compressions, pericardiocentesis, bypass, and sternotomy.A rv perforation was discovered and repaired, and the patient was placed on extracorporeal membrane oxygenation (ecmo) and transferred to the icu.The patient survived the procedure.This report captures the lld ez device providing traction to the rv lead when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• Brand Name: LLD EZ LEAD LOCKING DEVICE
• Common Device Name: STYLET, CATHETER
• 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: ayse kharodawala ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 24520736
• Report Number: 3007284006-2026-00067
• Device Sequence Number: 9746365
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)271210(10)0303656468
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142116
• 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): 03/05/2026

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: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: 0303656468
• 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: 02/13/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2025
• 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: MEDTRONIC 6947 RV ICD LEAD; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 11F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH; SPECTRANETICS LLD EZ LEAD LOCKING DEVICE; SPECTRANETICS SMALL VISISHEATH DILATOR SHEATH; ST. JUDE MEDICAL 1688TC RA PACING LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White