MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS 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	04/11/2023
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 investigation could be completed.H6): lld cut/cap is a known risk of complication with use of the lld device.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 atrial (ra) and a right ventricular (rv) lead due to non function.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Multiple spectranetics devices (glidelight laser sheath, visisheath dilator sheath, tightrail rotating dilator sheath) were used to attempt extraction.The ra and rv leads had significant calcified binding between them, and the leads began to snowplow (the insulation bunching up on itself).The leads could not be safely extracted, so they were abandoned.The lld within the ra lead was successfully unlocked and removed from the lead''s inner lumen.However, the lld within the rv lead could not be unlocked; therefore, the rv lead/lld were cut and capped and remained in the patient.The patient survived the procedure.This report captures the lld within the rv lead which was cut and capped and remained in the patient.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Common Device Name: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 16864617
• Report Number: 1721279-2023-00070
• Device Sequence Number: 5386075
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: (01)00813132023010(17)241116(10)FLC22L14A0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

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: 11/16/2024
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC22L14A
• 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: Not provided
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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 CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS GLIDELIGHT LASER SHEATH.; SPECTRANETICS LEAD LOCKING DEVICE IN RA LEAD.; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH.; SPECTRANETICS VISISHEATH DILATOR SHEATH.; ST. JUDE MEDICAL 2088TC RA PACING LEAD.; ST. JUDE MEDICAL 7120Q RV ICD LEAD.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White