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	01/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) and right atrial (ra) lead due to bacteremia.Spectranetics lld ez lead locking devices (lld ezs), along with cook medical bulldog lead extender, were inserted into each lead to provide traction.Utilizing a spectranetics 13f tightrail rotating dilator sheath (long) with outer sheath, spectranetics 13f tightrail sub-c rotating dilator sheath, and cook medical 11f evolution dilator sheath on the ra lead, the lead was successfully removed.Targeting the rv lead with the same devices, the high voltage cables began to externalize in the superior vena cava (svc)/innominate junction.The lead freed from the heart up to the rv coil, and a cook medical needle¿s eye snare was used for more traction.However, the lead, along with the lld, broke in the ra.Attempts to snare from the groin were unsuccessful; therefore, the decision was made to abandon the procedure.The lead and lld ez remained in the patient, and 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.A4) patient weight - not available from facility.A5/a6) patient ethnicity and race - 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 ; 719447-2465
• MDR Report Key: 24211555
• Report Number: 3007284006-2026-00037
• Device Sequence Number: 17507395
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)270313(10)0303431305
• 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): 01/29/2026

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: 0303431305
• 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: 01/15/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2025
• 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: ABBOTT 2088TC RA PACING LEAD; COOK MEDICAL 11F EVOLUTION DILATOR SHEATH; COOK MEDICAL BULLDOG LEAD EXTENDER; COOK MEDICAL NEEDLE'S EYE SNARE; MEDTRONIC 6935 RV ICD LEAD; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS LLD EZ LEAD LOCKING DEVICE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Male