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

Model Number 518-019

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

Patient Problems Pleural Effusion (2010); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 05/25/2022

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.Complete occlusion of the patient's system from the left side to the superior vena cava (svc) was noted.A right atrial (ra) lead was present within the patient, but was not targeted for extraction.Spectranetics lead locking devices (llds) were inserted into the rv and lv leads to provide traction.The physician began by using a spectranetics 14f glidelight laser sheath to attempt rv lead removal, but encountered stalled progress at the distal end of the lead''s proximal coil, so upsized to a 16f glidelight.Advancement was made past the svc, and the lead freed up with traction.The patient''s blood pressure dropped, and transesophageal echocardiography (tee) noted fluid in the pericardium.Rescue efforts began, including rescue balloon and pericardiocentesis to drain the blood.The pericardiocentesis had an immediate positive effect, and blood continued to be removed as the ct surgeon scrubbed in.Blood and platelets were administered to the patient.Fluid was also discovered within the left chest cavity, and the physician suspected the rv lead tip had been implanted or migrated through the pericardium and by pulling the lead, it perforated the rv apex and pericardium, thus explaining why effusions were present in both locations (mdr #1721279-2022-00115).The bleeding eventually stopped without surgical intervention.Multiple venograms were performed to check for svc injury, with no injury to that area detected.The extraction attempts stopped.The physician was able to successfully unlock the lld from the rv lead and removed the lld.He capped the rv lead and it remained within the patient.He attempted to unlock the lld from the lv lead without success so the lv lead/lld was cut and capped and remained within the patient (mdr #1721279-2022-00116).The plan is to remove the leads at a later time, once the patient is determined stable.This report captures the lld present within the rv lead when the suspected rv apex and pericardial perforations occurred, requiring intervention.There was no alleged malfunction of the lld within the rv lead during the procedure.

Manufacturer Narrative

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

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 14759877
• MDR Text Key: 295044122
• Report Number: 1721279-2022-00115
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023014
• UDI-Public: (01)20813132023014(17)231116(10)FLC21L10A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990713
• 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: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2023
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC21L10A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• 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 4194 LV LEAD; MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 6947 RV ICD LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE IN LV LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White