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

Model Number	518-039
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and right ventricular (rv) lead due to bacteremia.During preparation, the rv lead was removed successfully with manual traction.A spectranetics lld e lead locking device (lld e) was inserted into the ra lead to provide traction.Beginning with a spectranetics 11f tightrail sub-c rotating dilator sheath, it was noted that the lead was heavily calcified and resistance was encountered.Advancement was made just before the superior vena cava (svc), and upsized to a spectranetics 13f tightrail rotating dilator sheath.Resistance was observed on the entire length of the lead, but the ra lead was freed and extracted.However, the patient's blood pressure dropped, and rescue efforts began, including rescue balloon, cpr, blood product, medications, and sternotomy.An ra perforation was discovered and repaired, and the patient survived the procedure.This report captures the lld e providing traction on the ra lead when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
A3b) patient gender - not available from facility.A4) patient weight - not available from facility.B2) due to multiple failed submissions for entering 2 outcomes, adding here the additional outcomes attributed to adverse event: life threatening.B7) other relevant history - not available from facility.H3) the lld e 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.

• Brand Name: LLD E 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: 50091040
• Report Number: 3007284006-2026-00408
• Device Sequence Number: 21452430
• Product Code: DRB
• UDI-Device Identifier: 00813132023058
• UDI-Public: (01)00813132023058(17)270617(10)0303503971
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043401
• 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): 07/30/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 518-039
• Device Catalogue Number: 518-039
• Device Lot Number: 0303503971
• 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: 07/20/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2025
• 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 3830 RV pacing lead; Medtronic 5076 RA pacing lead; Spectranetics 11F TightRail Sub-C Dilator Sheath; Spectranetics 13F TightRail Dilator Sheath
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Race: White