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 Iatrogenic Source (2498); Cardiac Perforation (2513)

Event Date 02/04/2021

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to cied system/pocket infection (both leads implanted in 2010).Spectranetics lead locking devices (lld''s) were inserted into each lead to provide the traction platforms to aid in extraction.The physician then chose a spectranetics glidelight laser sheath, and the laser was used on both leads but did not progress beyond the subclavian/innominate region.Some lead on lead binding was noted in the proximal anatomy.The ra lead was then extracted successfully.During the rv lead extraction, an effusion was noted via transesophageal echocardiography (tee).Tamponade resulted.Rescue efforts began immediately.A pericardiocentesis was performed to remove blood from the pericardial space, and the patient stabilized.A cardiothoracic surgeon consulted and a sternotomy was performed.An injury to the right ventricle was discovered and was successfully repaired.The patient survived the procedure.This report is being submitted to capture the lld which was present within and provided traction to the rv lead when the rv injury was discovered.There was no alleged malfunction of any spectranetics device in use during the procedure.

Manufacturer Narrative

H6): manufacturer received an email from fda on 15 mar 2021 providing a list of mdr''s submitted by the manufacturer that included an invalid exemption number.The purpose of this supplemental report is to clarify that the mdr submitted is not the subject of an approved exemption and therefore number ¿5645646¿ included in the ¿exemption number¿ field was submitted in error.This exemption number has now been removed.

• 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: 11416413
• MDR Text Key: 245345836
• Report Number: 1721279-2021-00027
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023076
• UDI-Public: (01)20813132023076(17)220608(10)FLP20F05A
• Combination Product (y/n): Y
• PMA/PMN Number: K142116
• Exemption Number: 5645646
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2022
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP20F05A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICE; ST. JUDE MEDICAL 1688TC RA PACING LEAD; ST. JUDE MEDICAL 1688TC RV PACING LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR