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

Model Number 518-062

Device Problems Break (1069); Device Inoperable (1663)

Patient Problem Cardiac Tamponade (2226)

Event Date 12/15/2016

Event Type  Injury  

Event Description

This procedure was to extract a cardiac lead due to non-functioning.The leads were prepped with spectranetics lead locking devices.The physician indicated in their dictation that one of the lld's broke during use and the patient suffered a cardiac tamponade and a pericardial window was successfully performed.The broken device was retrieved from the patient.This report is being made against the lld breakage as the potential for injury.The patient survived the procedure.

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 6239181
• MDR Text Key: 64434180
• Report Number: 1721279-2017-00009
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• 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,Followup,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• 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: CARDIAC LEAD INFORMATION UNKNOWN; SPECTRANETICS CVX-300 LASER SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 66 YR