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

Model Number	518-062
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a capped right ventricular (rv) lead due to non-function.An active rv and active right atrial (ra) lead were present within the patient, but were not targeted for extraction.A spectranetics lld ez lead locking device (lld ez) was inserted into the lead to provide traction; however, during preparation of the capped rv lead, the high voltage cables broke at the clavicle and pulled out of the lead.Attempts were made to advance to the lld ez, only making it to the top of the superior vena cava (svc).The lld ez was retracted and a spectranetics lld #1 lead locking device (lld #1) was used with the same result, so the lld #1 was removed and the lld ez was inserted onto the lead again, locked, and suture was applied to the outer insulation of the lead.Beginning with a spectranetics 14f glidelight laser sheath, along with a spectranetics medium visisheath dilator sheath, the glidelight would not advance past the clavicle due to severe lead on lead binding.The decision was made to abandon the procedure for fear of damaging the untargeted leads.Attempts to unlock the lld ez from the capped rv lead were unsuccessful; therefore, the rv lead, along with the lld ez, were cut/capped and remained in the patient.The patient survived the procedure.This report captures the lld ez within the rv lead, which was cut/capped and remained in the patient.
Additional Manufacturer Narrative
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 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: 25587720
• Report Number: 3007284006-2026-00372
• Device Sequence Number: 17513349
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)280226(10)0303716909
• 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): 06/22/2026

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: 0303716909
• 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: 06/01/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2026
• 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 7122 RV ICD LEAD; MEDTRONIC 4076 RA PACING LEAD; MEDTRONIC 6935M RV ICD LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD #1 LEAD LOCKING DEVICE
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Race: Black Or African American