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

Model Number 518-019

Device Problem Insufficient Information (3190)

Patient Problems Endocarditis (1834); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930)

Event Date 03/31/2015

Event Type  Injury  

Event Description

Lead management case to extract three leads due to cied system/pocket infection.Patient presented with endocarditis and a large vegetation approximated at 2.7cm.All 3 leads were prepped for extraction (ra with an lld #2, rv with an lld ez, and the lv with an lld e).The physician successfully extracted the ra lead with a glidelight and then removed the rv lead using traction with the lld ez.At this point it was noted on tee that the vegetation was no longer visible; however the patient¿s hemodynamics remained stable.The physician then began to extract the lv lead with the glidelight and some mechanical manipulation.The patient suffered a dramatic decrease in blood pressure at that time.Extraction was abandoned by removing all lead extraction devices and the patient was placed on emco.No injury was noted and the physician believes the patient decline was the result of a pe.This report is to reflect the release of the vegetation when the rv lead was removed using the lld ez as the traction platform.

Manufacturer Narrative

(b)(4).

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD EZ
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal dr.; colorado springs CO 80917
• Manufacturer (Section G): SPECTRANETICS CORPORATION
• Manufacturer Contact: sondra chandler ; 9965 federal dr.; colorado springs, CO 80917 ; 719447-253
• MDR Report Key: 4671747
• MDR Text Key: 5619358
• Report Number: 1721279-2015-00056
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/12/2017
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLP15A12A
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2015
• 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
• Treatment: MDT 6935 RV CARDIAC LEAD (IMPL. 5MO); MDT 4087 RA CARDIAC LEAD (IMPL. 148MO); MDT 4195 LV CARDIAC LEAD (IMPL. 72MO); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE E; SPECTRANETICS LEAD LOCKING DEVICE #2; SPECTRANETICS GLIDELIGHT LASER SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 109