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

Model Number 518-062

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

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

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

Weight: patient weight is unavailable.Initial reporter: physician's email is unavailable.

Event Description

A philips representative reported that a cardiac lead management procedure commenced to extract five leads due to infection.The surgical access point was the right subclavian.Lead locking device (lld) was inserted for traction in all leads.Left ventricular (lv) lead was removed without issue.Spectranetics glidelight laser sheath was utilized to remove the icd lead, but met resistance in superior vena cava (svc).Physician switched to the ra lead which was removed without issue.The icd lead was removed with cook medical's evolution 11fr.Patient's blood pressure was 120/60 after ra lead was removed.After a few minutes the blood pressure began to steadily drop and cardiac tamponade was detected.Rescue efforts commenced including sternotomy.A right atrial perforation was detected and successfully repaired.The adverse event occurred while using cook evolution 11fr.However, since the spectranetics lead locking device was used as the traction platform this mdr is being filed.

• 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: 8778889
• MDR Text Key: 150687068
• Report Number: 1721279-2019-00119
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2021
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP19B20A
• 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: 06/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2019
• 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; Required Intervention
• Patient Age: 82 YR