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

Model Number 518-062

Device Problem Insufficient Information (3190)

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

Event Date 09/11/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

This was a bilateral lead extraction to remove 5 cardiac leads due to bacteremia.Each of the leads was prepped with an lld-ez and a 16f glidelight and 33 l visisheath was used to extract.During extraction of the sprint fidelis rv icd lead (6936, implanted 240 months) and as the lead pulled free, a large piece of tissue came free with the lead.The patient's blood pressure began to drop and emergent protocols were initiated (to include bypass, chest compressions, pericardiocentesis, and cv intervention without sternotomy access to free scar tissue and search for damage).Unfortunately, the patient did not survive the intervention.As the lld was the device used to prep the lead and 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: 5079418
• MDR Text Key: 25876114
• Report Number: 1721279-2015-00144
• 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: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/20/2017
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP15G20A
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2015
• 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
• Patient Outcome(s): Death
• Patient Age: 67 YR