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

Model Number	518-062
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Great Vessel Perforation (2152); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2) patient date of birth - not available from facility.A3b) patient gender - not available from facility.H3) a portion of the device was discarded, and a portion remained within the patient, thus no product investigation could be performed.H6) per ifu, perforation and lld cut/cap are listed as potential adverse events with use of the lld device.Although lld cut/cap is a known risk of complication with use of the lld, the physician did not attempt to unlock the lld ez from the lead prior to 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.
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead due to fracture and occlusion.A spectranetics lld ez lead locking device was inserted into the lead to provide traction.Beginning with a spectranetics 16f glidelight laser sheath, advancement was made down to the atrium.While pulling on the lld, the lead pulled back; however, the patient's blood pressure dropped and a pericardial effusion was detected via echo.Rescue efforts began, including rescue balloon and sternotomy.An inferior vena cava (ivc)/ra junction perforation was discovered, and believed to have been caused by pulling on the lead, which was adhered in the area creating the perforation.The injury was repaired, and the decision was made to abandon the procedure.The lld ez, along with the rv lead, were cut and capped, and remained in the patient.There was no attempt to unlock the lld ez, and the patient survived the procedure.This report captures the lld ez providing traction to the lead when the suspected perforation occurred, requiring intervention, and was cut/capped and remained in the patient.

• 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: 25535493
• Report Number: 3007284006-2026-00371
• Device Sequence Number: 21180918
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)271218(10)0303661874
• 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): 06/17/2026

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: 0303661874
• 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: 05/28/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2025
• 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 LDA220Q RV ICD LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Life Threatening; Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American