MAUDE Adverse Event Report: SPECTRANETICS CORPORATION LLD #2 LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number	518-019
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	03/07/2025
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.A5) patient ethnicity - not available from facility.A6) patient race - not available from facility.B7) other relevant tests/laboratory data - 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) 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.
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead and a right atrial (ra) lead due to non-function.Beginning with a spectranetics 14f glidelight laser sheath and traction with a non-philips fiber wire, the ra lead was removed.A spectranetics lld #2 lead locking device (lld #2) was then inserted into the rv lead to provide traction.However, the lld was unable to reach the tip of the lead, and the lead started to fall apart.Therefore, a cook medical bulldog lead extender was added to aid in traction.The 14f glidelight was unable to go over the lead, so upsized to a spectranetics 16f glidelight laser sheath.Progress was made to the innominate vein, but slowly advanced to the tip of the lead due to resistance.Switching to a spectranetics 13f tightrail rotating dilator sheath, progress was made up to the same point, when the patient¿s blood pressure dropped.Rescue efforts began, including rescue balloon.No effusion was detected via transesophageal echocardiogram (tee), but the blood pressure remained low (cause unknown), and no perforation or injury was identified.The decision was made to put the patient on extracorporeal membrane oxygenation (ecmo), and the rv lead was cut and capped, along with the lld, and remained in the patient.There was no attempt made to unlock the lld.The patient survived the procedure.This report captures the lld #2 within the rv lead, which was cut/capped and remained in the patient.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• Brand Name: LLD #2 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: 21692217
• Report Number: 3007284006-2025-00051
• Device Sequence Number: 9282062
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: (01)00813132023010(17)260809(10)0303314716
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K990713
• 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): 03/25/2025

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 Expiration Date: 08/09/2026
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: 0303314716
• 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: 03/10/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2024
• 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; FIBER WIRE (MANUFACTURER UNK); MEDTRONIC 3038 RA PACING LEAD; MEDTRONIC 5076 RV PACING LEAD; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 64 KG