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

Model Number 518-062

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946)

Event Date 12/16/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A lead management case to extract 2 cardiac leads.Both leads were prepped with an lld ez and a 16f glidelight was selected for use.Steady progress with the 16f glidelight was made up until the svc/ra junction requiring several consecutive laser trains.A significant drop in blood pressure was noted.Rescue interventions began and a sternotomy was performed revealing an svc/ra junction tear.Based on the location, appearance and type of injury the surgeon noted that the lead had become endothelialized within the vessel wall.A bovine patch was used and the tear was successfully repaired.Fragments of both leads were left in the patient along with the lld ezs that were in the leads.The patient survived the intervention.This adverse event is to reflect on one of the llds that was left in the body.The injury is reported under mdr# 1721279-2015-00205 and the other lld is reported under mdr# 1721279-2015-00206.

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: 5354871
• MDR Text Key: 35814444
• Report Number: 1721279-2015-00204
• 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: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/20/2017
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP15H20A
• 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: 08/20/2015
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 25 YR
• Patient Weight: 57