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 Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 09/25/2023

Event Type  Death  

Manufacturer Narrative

A2): patient''s date of birth, age unk.A4): patient''s weight unk.B7): other relevant history unk.D4): device lot number, expiration date unk.Partial udi populated.H3): the device was discarded, thus no investigation could be completed.H4): device manufacture date unk because lot number unk.H6): cardiac perforation and death are known risks 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 Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to bacteremia and cied system/pocket infection.Spectranetics lead locking devices (lld ezs) were inserted into each lead to provide traction.Beginning with the ra lead, a spectranetics 16f glidelight laser sheath was used to successfully extract the ra lead.Next, the glidelight was used on the rv lead, advancing with little effort to just above the tricuspid valve, and the rv lead came free and was removed.The glidelight was left in place to act as access for re-implantation of new leads.As a wire was being placed through the back of the glidelight to prepare for the implant, the patient's blood pressure dropped, and a pericardial effusion was detected.Rescue efforts began, including a sub-xiphoid window.However, due to the amount of bleeding, a sternotomy was performed and an rv perforation was discovered and repaired.After repair, the patient's heart was still beating, but then stopped.Despite efforts to shock the heart multiple times, the attempts to re-start the heart were unsuccessful and the patient did not survive.This event captures the lld providing traction in the rv lead when the perforation occurred, requiring intervention but resulting in death.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• 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: 17986673
• MDR Text Key: 326290733
• Report Number: 3007284006-2023-00041
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: BOSTON SCIENTIFIC 0673 RV ICD LEAD; BOSTON SCIENTIFIC 7741 RA PACING LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD EZ IN RA LEAD
• Patient Outcome(s): Required Intervention; Death; Life Threatening
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American