MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD

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

Patient Problems Iatrogenic Source (2498); Cardiac Perforation (2513)

Event Date 08/22/2018

Event Type  Injury  

Event Description

A lead extraction procedure reportedly commenced to extract two leads: a right ventricular (rv) and a right atrial (ra) lead due to infection.A spectranetics glidelight device and lead locking devices were in use, among other mechanical and laser sheaths with frequent switching of devices due to the complexity of the case.While removing the rv lead, it was impossible to reach the end of the lead with the extraction catheter due to the acute angulation of the tip where it was implanted in the apex of the heart.Reportedly, when pulling against the heart apex with use of the lld within the lead, the apex gave way.A small laceration in the myocardium led to the development of an acute tamponade, recognized by bedside echocardiography.Rescue efforts commenced immediately and a drain was placed.The patient survived the procedure and was subsequently discharged.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 7951911
• MDR Text Key: 123246522
• Report Number: 1721279-2018-00140
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,09/12/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/10/2018
• 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: SPECTRANETICS CVX-300 EXCIMER LASER; SPECTRANETICS GLIDELIGHT LASER SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention