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

Model Number 518-062

Device Problem Material Perforation (2205)

Patient Problem Pericardial Effusion (3271)

Event Date 04/07/2016

Event Type  Injury  

Event Description

Lead management procedure to extract two leads.Leads were prepped with llds and the leads were extracted using a glidelight laser sheath.After extraction a pericardial effusion was noted and the blood pressure dropped.A pericardiocentesis was performed stabilizing the patient's blood pressure.Patient survived the intervention.The physician believes the lead perforated during implant resulting in a perforation upon removal.This adverse event is being reported against the lld as it was the traction platform for lead tip removal contributing to the effusion.

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
• 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: 5602220
• MDR Text Key: 43509782
• Report Number: 1721279-2016-00055
• 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: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/07/2016
• Initial Date FDA Received: 04/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 07/24/2017
• Supplement Dates FDA Received: 05/10/2016; 03/23/2017; 08/16/2017
• 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: 62 YR