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 Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A3b): patient gender is unk.H3): the lld was discarded, thus no returned product investigation was performed.H6): cardiac perforation 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 right ventricular (rv), right atrial (ra), and left ventricular (lv) leads due to non-function and fracture.A spectranetics lld #2 lead locking device (lld #2) was inserted into the ra lead to provide traction.Beginning with a spectranetics 16f glidelight laser sheath on the ra lead, progress was made to the top of the superior vena cava (svc), where lead on lead binding would not allow for further advancement.Next, a spectranetics 13f tightrail rotating dilator sheath was used on the ra lead and the lead was removed; however, the patient's blood pressure dropped.A pericardial effusion was detected via transesophageal echocardiography (tee) and rescue efforts began, including sternotomy.An ra perforation was discovered and repaired.Another perforation in the innominate region was discovered and repaired, but the physician believed this occurred during the sternotomy.The rv and lv leads were not extracted and remained in the patient.The patient survived the procedure.This report captures the lld #2 providing traction within the ra lead, when the perforation occurred, requiring intervention.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: 20903128
• Report Number: 3007284006-2024-00239
• Device Sequence Number: 8906316
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: (01)00813132023010(17)260620(10)FLC24F13A
• 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): 12/11/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2026
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC24F13A
• 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: 12/04/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• 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: MEDTRONIC 1458Q LV LEAD; MEDTRONIC 4016 RA PACING LEAD; MEDTRONIC 4016 RV ICD LEAD; PHILIPS LASER SYSTEM; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White