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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
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.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Beginning with a spectranetics tightrail rotating dilator sheath, the ra and lv leads were removed successfully.Switching to the rv lead and when pulling on the lld ez, the lld ez broke proximal to the mandrel.The physician was still able to use the lld ez and the rv lead was removed.The patient survived the procedure.This report captures a portion of the lld ez that separated in the patient; potential for harm.
Additional Manufacturer Narrative
A2-a6) patient information - not available from facility.B6/b7) patient information regarding relevant tests/laboratory data or medical history - not available from facility.H3) the lld was returned without the proximal section (proximal loop, distal loop, and proximal connector).The returned section includes the remaining distal portion of the lld where it connects to the proximal connector.The length is 754 mm from the distal end of the lead to the proximal end of the lld; however, the overall lld measurement length could not be determined since it was stuck inside a portion of the lead.Visual inspection found multiple wrinkles, cuts, and rips in the outer jacket, along with broken and coiled braid.Biologics were present along the length of the device.At the location of the separation stretched/mangled wire was observed.H6) based on the device evaluation and investigation, the cause of the observed damage/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: 25490959
• Report Number: 3007284006-2026-00348
• Device Sequence Number: 16033018
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)271110(10)0303628894
• 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): 06/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 0303628894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2025
• 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: LV LEAD (MANUFACTURER, MODEL UNK); RA PACING LEAD (MANUFACTURER, MODEL UNK); RV LEAD (MANUFACTURER, MODEL, TYPE UNK); SPECTRANETICS TIGHTRAIL DILATOR SHEATH
• Patient Sex: Unknown