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

Model Number	518-067
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead and a right atrial (ra) lead due to bacteremia and cied system/pocket infection.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.A spectranetics 13f tightrail rotating dilator sheath was used to attempt removal of the leads; however, the device failed to actuate after minimal use in the innominate area.Switching to another tightrail device, cook medical evolution dilator sheath, and a cook medical bulldog lead extender from a femoral approach, the leads were still unable to be removed from the body.At that point, the decision was made to stop the extraction.There was no attempt made to unlock the llds from the rv and the ra (mdr #3007284006-2025-00019) lead; therefore, the ra lead was cut and capped, along with the lld, and remained in the patient.The rv lead was unable to be capped, and was just cut, along with the lld, and remained in the inferior vena cava (ivc) in the patient.The patient survived the procedure.This report captures the lld ez within the rv lead, which was cut and remained in the patient.There was no alleged malfunction of any spectranetics devices in use during the procedure.
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): although lld cut/cap is a known risk of complication with use of the lld, the physician did not attempt to unlock the lld from the lead prior to cutting and capping.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: 21265760
• Report Number: 3007284006-2025-00020
• Device Sequence Number: 19902527
• Product Code: DRB
• UDI-Device Identifier: 00813132023065
• UDI-Public: (01)00813132023065(17)261021(10)0303319519
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

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 Model Number: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: 0303319519
• 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: 01/17/2025
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2024
• 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: COOK MEDICAL BULLDOG LEAD EXTENDER; COOK MEDICAL EVOLUTION DILATOR SHEATH; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS LLD EZ ON RA LEAD; ST. JUDE MEDICAL 1488TC RV PACING LEAD; ST. JUDE MEDICAL 1888TC RA PACING LEAD
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Race: White