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 Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 02/21/2022

Event Type  Death  

Event Description

A lead extraction procedure commenced to remove three right ventricular (rv) leads (models 4012, 4076 and 4024) due to bacteremia.The patient had been admitted three times prior to procedure due to infection.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.It was reported that multiple spectranetics devices were in use during the procedure.Two leads (models 4012 and 4076) were removed successfully.Working on model 4024 using a spectranetics 13f tightrail rotating dilator sheath, resistance was met in the lower superior vena cava (svc) region and multiple activations of the tightrail device could not get past the binding that was encountered.Firm traction was applied to the lead for approximately twenty seconds, and the lead popped free.Upon removal of the lead, a large piece of tissue was noted with a yellow fat pad at the tip of the tissue.It was communicated that the injury was an rv apex perforation where the lead was originally implanted.The patient's blood pressure dropped and a pericardial effusion was noted on transesophageal echocardiography (tee).A pericardiocentesis was performed which improved blood pressure, and multiple transfusions were also given.The patient did not want an open procedure for rescue.The patient was stabilized at the time of the procedure, but passed away on the recovery floor of the facility later that day.This report captures the lld present in the rv model 4024 lead providing traction when the rv apex perforation occurred requiring intervention, but resulted in death.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

Patient's weight unk.Device lot number, expiration date unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.

• 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: 13863889
• MDR Text Key: 287709097
• Report Number: 1721279-2022-00056
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: 00813132023010
• 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: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2022
• 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: MEDTRONIC 4012 RV PACING LEAD; MEDTRONIC 4024 RV PACING LEAD; MEDTRONIC 4076 RV PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White