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

Model Number	518-067
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3/h6) the lld ez was not returned, thus no product investigation was performed.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.A spectranetics lld ez lead locking device (lld ez), along with a cook medical one-tie compression coil, were inserted into the lead to provide traction.Beginning with a spectranetics 9f tightrail rotating dilator sheath, the outer sheath would not enter the access site at the subclavian vein, thus unable to advance to the superior vena cava (svc)/ra junction.During removal, the tightrail (mdr #3007284006-2025-00136) got stuck on the lld ez (mdr #.), and both were removed together, along with the one-tie.Upon removal, the lld ez and one-tie could not be removed from the tightrail; therefore, the tightrail was cut to preserve the lead and lld ez length.A cook medical needle¿s eye snare was used to complete the procedure with no reported patient harm.This report captures the lld ez that got stuck on the concomitant devices that had to be removed as a system, potential for harm with recurrence.
Additional Manufacturer Narrative
H3) the lld was returned in two sections, which aligns that the device was intentionally cut by the user.The lld was stuck inside the tightrail¿s distal and proximal portion of the inner lumen with heavy biologics present.The distal portion of the tightrail was cut in half where the coils were exposed, and at the proximal half, 35 mm of the lld braid was removed.At the returned proximal portion of the tightrail , the lld mandrel was visible by x-ray.During functional testing, an attempt was made to remove the remaining lld from the distal half of the cut tightrail, but the lld moved slightly and remained inside the lumen.H6) based on the device evaluation and investigation, it has been determined that the probable cause of the lld becoming stuck in the tightrail was due to the excessive buildup of biologics and additional concomitant devices within the tightrail.Therefore, it is likely the lld became stuck within the inner coils of the tightrail, resulting in the experienced failure.Type of investigation code b01 replaced (from b17).Investigation findings code c0706 replaced (from c20).Investigation conclusions code d1001 and d20 replaced (from d14).All other codes are applicable as listed in the initial mdr.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: 22493187
• Report Number: 3007284006-2025-00137
• Device Sequence Number: 11792629
• Product Code: DRB
• UDI-Device Identifier: 00813132023065
• UDI-Public: (01)00813132023065(17)270310(10)0303425795
• 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,Followup
• Report Date (Section B): 10/06/2025

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: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: 0303425795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• 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: COOK MEDICAL ONE-TIE COMPRESSION COIL; MEDTRONIC RV LEAD (MODEL, TYPE UNK); SPECTRANETICS 9F TIGHTRAIL DILATOR SHEATH
• Patient Age: 7 YR
• Patient Sex: Male