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

Model Number	518-019
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3): a portion of the device was discarded and a portion remained in the patient, thus no device evaluation could be completed.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.
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead due to occlusion and non function.A right atrial (ra) lead was present in the patient as well, but was not targeted for extraction.A spectranetics lld #2 lead locking device (lld #2) was inserted into the lead to provide traction.Beginning with a spectranetics 13f tightrail sub-c rotating dilator sheath followed by a 13f tightrail (long), attempts were made to advance past the occlusion.During the procedure, access was gained using a wire, and a new rv lead was implanted.At that time, the decision was made to stop any further extraction attempts, leaving the non functional rv lead in place.Attempts were made to unlock the lld #2 from the rv lead, but were unsuccessful; therefore, the rv lead/lld were cut and capped and remained in the patient.The patient survived the procedure.This report captures the lld #2 within the rv lead which was cut and capped and remained in the patient.

• 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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 19680312
• Report Number: 3007284006-2024-00140
• Device Sequence Number: 15182942
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: (01)00813132023010(17)250523(10)FLC23E18A
• 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): 07/05/2024

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: 05/23/2025
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC23E18A
• 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: 06/13/2024
• Initial Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2023
• 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: SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH.; SPECTRANETICS TIGHTRAIL SUB-C DILATOR SHEATH.; ST. JUDE MEDICAL 1388TC RA PACING LEAD.; ST. JUDE MEDICAL 1388TC RV PACING LEAD.
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White