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 Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
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 cied system/pocket infection.During preparation of the leads, the lv lead was extracted with manual traction.Spectranetics lld ez lead locking devices (lld ezs) were inserted into the ra and rv lead to provide traction.Utilizing multiple spectranetics devices (14f glidelight laser sheath, 16f glidelight laser sheath, medium visisheath dilator sheath, large visisheath dilator sheath, 11f tightrail sub-c rotating dilator sheath, and 13f tightrail sub-c rotating dilator sheath) on the ra and rv lead, the devices were unable to pass the clavicle and first rib junction.After several attempts, both the leads broke and the decision was made to snare the leads from the groin.The ra lead was removed; however, the rv lead would not release from the clavicle/rib junction or the distal tip of the rv apex.The rv lead stretched, and broke at the clavicle, along with the lld ez.The rv lead and lld ez remnant were abandoned and remained in the patient.The patient survived the procedure.This report captures a portion of the lld ez within the rv lead that separated, along with the lead, and retained in the patient.
Additional Manufacturer Narrative
A3b) patient gender - not available from facility.H3/h6) a portion of the device was retained at the facility and a portion remained within the patient, thus no product investigation was performed, and the cause of the reported failure could not be established.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: 50330333
• Report Number: 3007284006-2026-00423
• Device Sequence Number: 5469097
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)280324(10)0303736670
• 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): 08/19/2026

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: 0303736670
• 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: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2026
• 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: Medtronic 3830 LV lead; Medtronic 5086 RA pacing lead; Medtronic 5086 RV pacing lead; Spectranetics 11F TightRail Sub-C Dilator Sheath; Spectranetics 13F TightRail Sub-C Dilator Sheath; Spectranetics 14F GlideLight Laser Sheath; Spectranetics 16F GlideLight Laser Sheath; Spectranetics CVX-300 Excimer Laser System; Spectranetics LLD EZ Lead Locking Device; Spectranetics large VisiSheath Dilator Sheath; Spectranetics medium VisiSheath Dilator Sheath
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 182 LB
• Patient Race: White