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

Model Number 518-067

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); Iatrogenic Source (2498); Cardiac Perforation (2513)

Event Date 09/25/2019

Event Type  Injury  

Manufacturer Narrative

The device was discarded.There is no allegation of a malfunction.Therefore, no device evaluation will be performed.

Event Description

A lead management procedure commenced to extract one right atrial (ra) and one right ventricular (rv) lead, due to infection.Both leads were implanted in (b)(6) 1996.There was calcification and adhesion of both leads.The spectranetics lead locking device (lld-ez) was inserted into both leads as the traction device.A 12fr and 14fr spectranetics glidelight laser sheath and 14f were utilized on the rv lead first, but became stuck in the subclavian vein.The physician switched to ra lead but met resistance in the same area.They used a cook evolution 11fr device and progressed to the innominate vein.They tried to progress both leads alternately but became stuck again in the superior vena cava (svc).The physician decided to changed extraction method and approached from the femoral vein using a needle eye snare.Although both leads were binding, the physician was able to grasp the leads and cut the leads with llds inside.After cutting the leads, they attempted to pull them out.The tip of the ra lead was free and patient's blood pressure began to drop.Cardiac tamponade was detected.Rescue interventions were implemented, including sternotomy.A 1cm tear was found in the ra and repaired successfully.Both leads were removed successfully using snare when the chest was open.The chest was closed and patient was transferred to icu.The patient was survived procedure.The physician said the spnc device was not related to this event.This report is being filed as the lld was utilized during the procedure.There is no allegation that the lld malfunctioned or caused/contributed to the injury.

• 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: 9182999
• MDR Text Key: 162496027
• Report Number: 1721279-2019-00180
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2021
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: FLP19F10A
• 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: 09/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2019
• 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
• Patient Age: 82 YR
• Patient Weight: 55