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

Model Number 518-062

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); Pericardial Effusion (3271)

Event Date 11/22/2023

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) and a left ventricular (lv) lead due to non function.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath on the lv lead, advancement was made only into the subclavian when the lv lead released.Next, using the same 14f glidelight and a spectranetics visisheath dilator sheath, the rv lead was extracted without issues, and a new rv lead was re-implanted.Then, while preparing for the new lv lead re-implantation, the patent's blood pressure dropped and a posterior effusion was detected (not present when lv lead was extracted), via transesophageal echocardiography (tee).Rescue efforts began, including a pericardial window, and a small, lateral cardiac vein perforation was suspected.A clot was removed, and a drain was placed.The patient survived the procedure.This report captures the lld providing traction within the lv lead, when the suspected perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

H3): the device was discarded, thus no investigation could be completed.H6): perforation of vessels 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 EZ LEAD LOCKING DEVICE
• Type of Device: 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 ; 719447-246
• MDR Report Key: 18314930
• MDR Text Key: 330329161
• Report Number: 3007284006-2023-00092
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023076
• UDI-Public: (01)20813132023076(17)251016(10)FLP23K16A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP23K16A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MEDTRONIC 4196 LV LEAD; MEDTRONIC 6944 RV ICD LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD EZ IN RV LEAD; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian