MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD #2

Model Number 518-019

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

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Tissue Damage (2104); Blood Loss (2597)

Event Date 01/29/2016

Event Type  Death  

Manufacturer Narrative

Placeholder.

Event Description

Lead management case to extract one non-functional cardiac lead.The lead was prepped with an lld #2 and lasing began with a 16f glidelight.Approximately midway through the proximal coil the lead came free from the myocardium and was removed.The tip of the lead was observed to have large amounts of tissue attached from the explant site.At that time the patient's blood pressure began to drop.A sternotomy was performed and a perforation of the coronary sinus was identified.The lead had been originally implanted in the cs and upon removal at the implant site a perforation occurred.The perforation was repaired; however additional complications occurred during cannulation of the aorta for bypass resulting in a significant bleed.The patient experienced significant vf and could not be rescued.The glidelight in this case was not advanced to the area of the injury so this report is to reflect on the lld as it was the traction platform used to remove this lead at time of injury.

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 #2
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal dr; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: jason hearn ; 9965 federal dr.; colorado springs, CO 80921 ; 719447-236
• MDR Report Key: 5449275
• MDR Text Key: 38631805
• Report Number: 1721279-2016-00024
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990713
• 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: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• 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
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Weight: 66