MAUDE Adverse Event Report: SPECTRANETICS CORPORTATION SPECTRANETICS LEAD LOCKING DEVICE; LLD EZ

Model Number 518-062

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hemorrhage/Bleeding (1888); Cardiac Perforation (2513)

Event Date 03/10/2014

Event Type  Injury  

Event Description

Lead management case to extract leads due to cied pocket infection.The patient had 3 leads implanted from the right side and was pacer dependant.The physician began by putting a temporary pacer in place and dissected the pocket.The rv and lv leads were removed with manual traction only without devices.The ra lead was prepped with an lld ez.Extraction began with a 14fr glidelight and visisheath; upon reaching the right atrium the lead released from the cardiac wall and was removed.Upon tee and x-ray blood was identified in the pleural space.A sternotomy was performed where a hole in the right atrium was repaired.This injury was most likely caused by the removal of the lead from the cardiac tissue causing a perforation in the right atrium; due to the lld being used as the traction platform within that lead, the lld is the most likely contributory device.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD EZ
• Manufacturer (Section D): SPECTRANETICS CORPORTATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORTATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: sondra chandler rn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472530
• MDR Report Key: 3677874
• MDR Text Key: 4255148
• Report Number: 1721279-2014-00045
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043401
• 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: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/04/2015
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP13J04A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2013
• 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: SPECTRANETICS 14 FR GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; ST. JUDE 7122Q LEAD (IMPL. (B)(6) 2011); ST. JUDE 1458Q LEAD (IMPL. (B)(6) 2011); CARDIAC LEAD IML49JB- UNK MAKE (IMPL. (B)(6) 2001); SPECTRANETICS VISISHEATH M MEDIUM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 97 YR
• Patient Weight: 77