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

Model Number 518-062

Device Problem Mechanical Problem (1384)

Patient Problems Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)

Event Date 02/19/2019

Event Type  Injury  

Manufacturer Narrative

Device remains within patient.Therefore, no device evaluation will be performed.Instructions for use for this device state: warning: excessive applied traction forces may impact the lld¿s ability to disengage from a lead.

Event Description

A philips representative reported that a cardiac lead management procedure commenced to extract 3 non-functional/redundant leads.The physician prepped 2 of the leads for extraction (1 right atrial and 1 right ventricular) with a spectranetics lead locking device (lld) ez 518-062.The physician decided to abandon the extraction of the rv and ra leads after several attempts with no progress at an adhesion sight in the superior vena cava (svc).He attempted to unlock the lld ez, but was unable to and the lld was cut, capped within the respective lead, and left within the patient.The physician did not complete the lead extraction for any of the leads.However, he did manage to get access and complete the re-implant of a biv device.This mdr is being filed to capture the lld cut and capped within the ra lead.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: catherine eaton ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 8430446
• MDR Text Key: 139164205
• Report Number: 1721279-2019-00047
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• 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
• Report Date: 01/01/2005,02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP17L13A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2017
• 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): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 82