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

Model Number 518-062

Device Problem Detachment Of Device Component (1104)

Patient Problems Death (1802); Sepsis (2067); Ventricular Fibrillation (2130); Cardiac Tamponade (2226)

Event Date 01/22/2016

Event Type  Death  

Event Description

Lead management procedure to extract 3 leads due to septicemia.Each lead was prepped using an lld ez.The rv lead (7120) was extracted using traction only on the lld ez.The physician used a 12f and 16f sls in an alternating fashion to extract the ra lead (5556).The 16f sls was advanced on the rv lead (0125) and when the laser reached the svc the lead tip came free.Immediately after the tip came free a cardiac tamponade was noted.A sternotomy was performed and a tear of the ventricular wall was repaired.The patient was discharged to icu and later passed due to sepsis and ventricular fibrillation.This adverse event is to reflect on the lld ez that was used as the traction platform in the lead as this was the contributory device for the lead tip removal resulting in the injury.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD EZ
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal dr; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: sondra chandler ; 9965 federal dr; colorado springs, CO 80921 ; 719447-253
• MDR Report Key: 5430558
• MDR Text Key: 38026823
• Report Number: 1721279-2016-00018
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P960042
• 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: 01/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 518-062
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2015
• 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 12F LASER SHEATH
• Patient Outcome(s): Death
• Patient Age: 76 YR