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

Model Number 518-062

Device Problem Insufficient Information (3190)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 12/23/2015

Event Type  Injury  

Manufacturer Narrative

Placeholder.

Event Description

Lead management case to extract three leads due to cied system/pocket infection.The physician prepped the leads with llds and used a glidelight to remove adhesions.While on the ra lead the physician successfully freed all adhesions and applied traction on the lld.After the lead popped free of the myocardium a drop in bp was noted.A pericardial window was performed relieving the patient.A minor tear was thought to have been in the ra where the lead released from the myocardium; no other evidence of injury could be found.No other intervention was needed and the patient survived.This report is to reflect on the lld that was used as it was the traction platform in which to remove the lead.

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; CO
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 5354883
• MDR Text Key: 35530176
• Report Number: 1721279-2015-00207
• 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,Followup
• Report Date: 12/23/2015

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 Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNKNOWN
• 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
• 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: 70 YR