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

Model Number 518-062

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

Patient Problems Perforation of Vessels (2135); Iatrogenic Source (2498)

Event Date 06/27/2018

Event Type  Injury  

Event Description

A procedure commenced to extract four leads: one right atrial (ra), one right ventricular (rv), and two left ventricular (lv) leads (one implanted in 2005 and one implanted in 2015) due to bacteremia.Spectranetics glidelight model 500-302 and lld was in use.While removing the older lv lead, the glidelight was placed into the coronary sinus (did not lase in this area) and countertraction was used with use of the lld, and the lead freed.However, a small posterior effusion was noted upon removal of this lead.Rescue efforts began, using pericardiocentesis and blood transfusions.Patient survived the procedure.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 7708349
• MDR Text Key: 114670883
• Report Number: 1721279-2018-00091
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): Y
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,06/27/2018

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
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• 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: 06/27/2018
• Initial Date FDA Received: 07/20/2018
• Supplement Dates Manufacturer Received: 07/25/2018
• Supplement Dates FDA Received: 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 122