MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS 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 09/15/2021

Event Type  Injury  

Manufacturer Narrative

The device was discarded, thus no investigation could be completed.

Event Description

A lead extraction procedure commenced to remove two right ventricular (rv) icd leads, one implanted in 2016 and one implanted in 2005.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.A spectranetics tightrail sub-c rotating dilator sheath was also used to free up both leads.While advancing to the superior vena cava/innominate junction, both leads pulled out without issue.Approximately 2 minutes after the leads were removed, the patient's blood pressure dropped.Rescue efforts began immediately, including chest compressions and rescue balloon.Transesophageal echocardiography (tee) confirmed that there was an effusion.A sternotomy was performed, 400 cc of blood was removed from the pericardial space, and a defect was noted in the rv apex.It was thought that during the initial lead implant in 2005 that the lead had perforated the rv apex but at that time did not produce any complications.When it was extracted, it allowed blood to exit the rv apex and form an effusion.The repair was successful and the patient survived the procedure.This report captures the lld providing traction to the rv lead (implanted in 2005) when the rv apex perforation occurred.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 12616136
• MDR Text Key: 283237569
• Report Number: 1721279-2021-00189
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2023
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP21E14A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDTRONIC 6935 RV ICD LEAD; SPECTRANETICS LLD IN RV LEAD IMPLANTED 2016; SPECTRANETICS TIGHTRAIL SUB-C DILATOR SHEATH; ST. JUDE MEDICAL 1580 RV ICD LEAD
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 87