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

Model Number 518-062

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 11/26/2014

Event Type  Injury  

Event Description

Lead management case to extract two cardiac leads due to bacteremia.The physician first extracted the rv (7000) lead without difficulty.The ra (1688) lead was prepped with an lld and extraction began using a glidelight.The physician advanced the laser sheath to the distal tip of the lead without complication.Traction was placed on the lead with the lld and the lead popped free from the cardiac wall.At that time, the patient's blood pressure dropped and an effusion was noted on tee.The surgeon performed a sternotomy identifying and repairing a tear in the rv.The patient survived the intervention.It is the opinion of the physician that this injury was caused from the lead releasing from the cardiac wall.This report is being made to reflect on the lld since it was used as the traction platform to pull the lead tip from the cardiac wall.

Manufacturer Narrative

(b)(4).

• 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: 4348479
• MDR Text Key: 19971440
• Report Number: 1721279-2014-00215
• 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: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• 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: 518-062
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2014
• 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: SJM 1688 CARDIAC LEAD (IMPL. 96 MO); SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SJM 7000 CARDIAC LEAD (IMPL. 96 MO)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 25 YR
• Patient Weight: 73