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	10/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra), a left ventricular (lv), and two right ventricular (rv, one active, one redundant) leads due to needing an mri compatible system, and a redundant rv lead.Prior to the procedure, the patient's vessels were heavily calcified, with the leads bound together.Spectranetics lead locking devices (an lld # 2 in ra, lld e in lv, lld ez in active rv, lld # 2 in redundant rv) were inserted into each lead to provide traction.Beginning with a spectranetics 13f tightrail rotating dilator sheath on the active rv lead, the patient's blood pressure slowly declined due to traction, but was removed with no evidence of injury.Next, the ra was targeted, using the same 13f tightrail.The ra lead was removed; however, the patient's blood pressure continued to decline, and a pericardial effusion was detected via transesophageal echocardiography (tee).Rescue efforts began, including pericardiocentesis, with 400 cc blood drawn off the heart.Over the next 90 minutes, more blood was removed; therefore, a sternotomy was performed.A small perforation in the inferior rv was discovered (mdr #.); the surgeon plugged the hole with his finger and placed a stitch in the perforation to repair.At that time, it was decided that the lead extraction would not continue.The physician did not attempt to unlock the remaining llds from the lv and redundant rv leads, so the lv lead/lld e (mdr #3007284006-2024-00221) and the redundant rv lead/lld #2 (mdr #3007284006-2024-00222) were cut and capped and remained in the patient.The patient survived the procedure.The physician believed that the rv perforation was caused while removing the ra lead, due to binding of the ra/redundant rv leads.The remaining two leads were successfully removed (b)(6) 2024.This report captures the lld # 2 providing traction within the ra lead, when the rv perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
The lld was not returned, thus no returned product investigation was performed.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.

• 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: 20613253
• Report Number: 3007284006-2024-00220
• Device Sequence Number: 21037866
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: (01)00813132023010(17)260212(10)FLC24B06A
• 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): 11/05/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2026
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC24B06A
• 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: 10/28/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2024
• 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 4193 LV LEAD; MEDTRONIC 4524 RA PACING LEAD; MEDTRONIC 4524 REDUNDANT RV PACING LEAD; MEDTRONIC 6947 ACTIVE RV PACING LEAD; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD #2 IN REDUNDANT RV LEAD; SPECTRANETICS LLD E WITHIN LV LEAD; SPECTRANETICS LLD EZ IN ACTIVE RV LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White