MAUDE Adverse Event Report: SPECTRANETICS CORPORATION LLD #2 LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number	518-019
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and three right ventricular (rv) leads due to fracture, non-function, and redundancy.A spectranetics lld #2 lead locking device (lld #2), spectranetics lld e lead locking devices (lld es), and spectranetics lld #1 lead locking devices (lld #1s), were inserted into each lead to provide traction.Multiple spectranetics devices (13f tightrail sub-c rotating dilator sheath, 13f tightrail (long), and 16f glidelight laser sheath) were used during the procedure.The rv lead, implanted in 2024, was removed with no issues.However, efforts were made to remove the other 3 leads but were unsuccessful.As a result, the decision was made to stop the extraction.Failed attempts were made to unlock the llds from the rv lead, implanted in 2009.The ra lead, implanted in 2009 (mdr#: 3007284006-2025-00031), and the rv lead, implanted in 2018 (mdr#: 3007284006-2025-00032), so the leads, along with the llds, were cut and capped and remained in the patient.The patient survived the procedure.This report captures the lld #2 within the rv lead, implanted in 2009, which was cut and capped and remained in the patient.
Additional Manufacturer Narrative
H3) a portion of the device was discarded, and a portion remained within the patient, thus no product investigation could be performed.H6): lld cut/cap is a known risk of complication with use of the lld.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 #2 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: 21422502
• Report Number: 3007284006-2025-00030
• Device Sequence Number: 7763793
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: (01)00813132023010(17)260620(10)FLC24F13A
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K990713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2026
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC24F13A
• 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: 02/11/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• 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 DURATA (MODEL UNK) RA PACING LEAD.; ABBOTT DURATA (MODEL UNK) RV PACING LEAD.; ABBOTT DURATA (MODEL UNK) RV PACING LEAD.; ABBOTT DURATA (MODEL UNK) RV PACING LEAD.; PHILIPS LASER SYSTEM.; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH.; SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH.; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH.; SPECTRANETICS LLD #1 LEAD LOCKING DEVICES.; SPECTRANETICS LLD ES LEAD LOCKING DEVICES.
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American