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

Model Number 518-062

Device Problem Entrapment of Device (1212)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Perforation (2001)

Event Date 10/29/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

Lead management case to extract 3 leads due to cied system/pocket infection.Patient presented in an extremely poor state of health ((b)(6), iv drug user) and was currently on a ventilator.The physicians involved in this case opted to proceed with the procedure knowing that due to the patient's state of health the risk of an adverse event during this procedure was higher; however without lead removal the patient status would lead to certain death.The procedure began by prepping the leads with llds.The ra lead and one rv lead were removed using a 14f glidelight and tightrail.Upon attempt to remove the other rv lead ((b)(4)) significant binding was encountered requiring the physician to upsize to a 16f glidelight.The glidelight was successfully advanced over the coils of the rv lead into the ra.Steady traction was then applied to the lead and the lead popped free from the myocardium.At this time a steady decline in blood pressure was noted and pressure could not be stabilized.The decision was made to perform a sternotomy revealing a perforation of the rv apex.The patient is currently in critical condition.This physician believed this injury was likely caused either by a perforation caused during original lead implant or caused by the lead pulling free from the cardiac wall but most likely contributed to by the patient's poor state of health.This complaint will reflect on the lld as it was the traction platform used to remove the lead; therefore being a potential contributory device.

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 dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 5208863
• MDR Text Key: 30682154
• Report Number: 1721279-2015-00171
• 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: 10/29/2015

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 Expiration Date: 07/22/2014
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP14G22A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 11/06/2015
• Supplement Dates Manufacturer Received: Not provided; 08/17/2017
• Supplement Dates FDA Received: 03/22/2017; 08/23/2017
• 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: 69 YR