MAUDE Adverse Event Report: Spectranetics Corporation LLD EZ Lead Locking Device; Stylet, Catheter

Model Number	518-062
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	09/18/2026
Type of Reportable Event	Death
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead due to fracture.A right atrial (ra) lead was present within the patient, but was not targeted for extraction.A spectranetics lld ez lead locking devices (lld ez) was inserted into the lead to provide traction.During extraction, utilizing multiple spectranetics devices (glidelight laser sheath, visisheath dilator sheath, tightrail sub-c rotating dilator sheath, and tightrail rotating dilator sheath), the lead, along with the lld broke in the subclavian.Switching to a merit medical needle's eye snare, attempts were made to snare from the groin; however, the snare broke and a abbott agilis catheter was then used.After several attempts to dislodge the lead, a pericardial effusion was noted in the rv apex, and rescue efforts began, including pericardiocentesis and sternotomy.An rv perforation was discovered and repaired, and the rv lead was removed.The patient was transferred to the icu in critical condition, and made no improvement in the following days.Care was withdrawn and the patient did not survive.This report captures the lld that broke, and perforation occurred, requiring intervention, but resulting in death.
Additional Manufacturer Narrative
B6/b7) patient information regarding relevant tests/laboratory data or medical history - not available from facility.H3) the lld was discarded, thus no product investigation was performed.H6) per ifu, perforation and death are listed as potential adverse events with use of the lld device.Additional health effect impact code: f15 recognised device or procedural complication.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: 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: nicole worford ; 9965 federal drive; colorado springs, CO 80921 ; +1(719)447-2465
• MDR Report Key: 50946464
• Report Number: 3007284006-2026-00464
• Device Sequence Number: 18516329
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)280727(10)0303810332
• 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): 09/30/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: 0303810332
• 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: 09/18/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2026
• 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: Abbott Agilis catheter.; Medtronic 5086 RV pacing lead.; Merit Medical Needle's Eye Snare.; Metronic 5086 RA pacing lead.; Philips Laser System.; Spectranetics GlideLight Laser Sheath.; Spectranetics TightRail Dilator Sheath.; Spectranetics TightRail Sub-C Dilator Sheath.; Spectranetics VisiSheath Dilator Sheath.
• Outcome Attributed to Adverse Event: Life Threatening; Death
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 200 LB
• Patient Race: Black Or African American