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

Model Number 518-062

Device Problem Device Inoperable (1663)

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

Event Date 08/24/2015

Event Type  Injury  

Event Description

This was a right-sided lead extraction procedure to remove two cardiac leads due to cied system infection/bacteremia and a non-functional lead.Each of the leads was prepped with an lld-ez.After a difficult extraction of the atrial lead (856a, impl 246 months) with a 14f glidelight laser sheath and an 11f tightrail sheath, the physician moved to the ventricular lead (448v, impl 246 months) with the 14f glidelight and was able to get the tip of the laser catheter to approximately 6-7 cm from the ring on the lead.Due to snowplowing of the insulation of the lead, the physician upsized to a 16f glidelight, freeing up the lead to about 1 cm from the tip.The physician gently pulled on the lead and was able to free it, noticing tissue at the tip.At this time, the patient's blood pressure declined and tee visualized fluid in the pericardium.A pericardiocentesis was performed without resolution, followed by a sternotomy.An injury in the rv apex was discovered and repaired.The tined ventricular lead was non-functional without known cause prior to the extraction; however after close inspection of the lead tip and surrounding tissues during the open procedure, it was discovered that the lead had perforated the myocardium years prior and this explains why it was no longer functional.This issue was not visible on x-ray prior to the procedure.The patient survived the intervention.The physician stated that the lead caused the injury as it was pulled free from the myocardium.Because the lld was the traction platform used to pull the lead free from the myocardium, it is the suspect device in this case.

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-EZ
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 5032708
• MDR Text Key: 24162685
• Report Number: 1721279-2015-00135
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 08/24/2015

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: Physician
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNKNOWN
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Supplement Dates Manufacturer Received: Not provided; 08/17/2017
• Supplement Dates FDA Received: 03/22/2017; 08/22/2017
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 85