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 08/24/2022

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right ventricle (rv), right atrium (ra), and left ventricle lead (lv) due to infection.The physician prepped all leads with spectranetics lead locking devices (llds) and used a spectranetics glidelight laser sheath to aid in the extraction.The ra and rv lead were removed successfully.After the lv lead was removed, transesophageal echocardiogram (tee) confirmed a pericardial effusion and the patient''s blood pressure dropped.Rescue efforts began, including pericardiocentesis.A drain was placed to remove the blood from the pericardial sac, and the patient''s blood pressure improved.A sternotomy followed, and a coronary sinus perforation was discovered and repaired successfully.The patient survived the procedure.This report captures the lld providing traction within the lv lead when the coronary sinus perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

Other relevant history unk.Device was discarded, thus no investigation could be completed.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.

• 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: nicole worford ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 15451182
• MDR Text Key: 300216589
• Report Number: 1721279-2022-00171
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: (01)00813132023010(17)231110(10)FLC21L08A
• 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: 09/19/2022

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 Expiration Date: 11/10/2023
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC21L08A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2022
• Initial Date FDA Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• 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: BOSTON SCIENTIFIC 0185 RV PACING LEAD; BOSTON SCIENTIFIC 4471 RA PACING LEAD; BOSTON SCIENTIFIC 4549 LV LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICES
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White