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

Model Number 518-067

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Injury (2348); Pericardial Effusion (3271)

Event Date 04/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Lead management procedure to extract two leads to cied system change to an mri compatible pacemaker.Each lead was prepped with an lld ez.The rv lead was successfully extracted using a 16f sls.Three minutes after removal of the rv lead the blood pressure dropped.A pericardial effusion at the cardiac apex was confirmed.The physician tried to extract the ra lead with traction only resulting in successful extraction.Medication and blood were given increasing the blood pressure for only ten minutes.Another transfusion was given; however the patient's blood pressure did not increase.A pericardiocentesis was performed ultimately stabilizing the patient's blood pressure.The patient survived the intervention.Based on injury type this injury most likely occurred upon release of the lead from the myocardium; this adverse event will be attributed to the lld as it was the traction platform used on the rv lead allowing tip release.

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: jason hearn ; 9965 federal dr.; colorado springs, CO 80921 ; 719447-236
• MDR Report Key: 5602240
• MDR Text Key: 43510913
• Report Number: 1721279-2016-00053
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/02/2017
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: FLP15J02A
• 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
• Date Device Manufactured: 09/02/2015
• 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: 65 YR