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 Iatrogenic Source (2498); Cardiac Perforation (2513)

Event Date 11/26/2019

Event Type  Injury  

Manufacturer Narrative

Device lot number and expiration date unavailable.Device manufacture date unavailable because lot number is unavailable.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead; the lead was no longer needed, and a biventricular pacemaker with an implantable cardioverter defibrillator (biv icd) upgrade was planned.A right atrial (ra) lead was present as well within the patient, but this lead was not targeted for extraction.Spectranetics glidelight laser sheath and lead locking device (lld) were being used in the procedure.During the procedure, it was noted that there was ''tough'' lead on lead binding at the entrance to the superior vena cava (svc).At that time, the physician chose to upsize to a larger glidelight device and was able to progress to approximately one inch proximal of the tip of the rv lead.The lead released at that time, and patient's vital signs were stable.The glidelight, along with the lead, were removed from the patient's body.Approximately 30 seconds later, the patient's blood pressure steadily dropped, and the left heart border was observed as not moving.Transesophageal echocardiography (tee) revealed a very small effusion in the right ventricle (rv).Rescue efforts commenced, including rescue device, subxyphoid window, and pericardiocentesis.The physician was performing the pericardiocentesis and was having difficulty due to a clot.At that time, the surgeon performed a full sternotomy.The surgeon noted that the rv was ''stuck to almost sealed to the diaphragm''.When he unstuck them, he removed a large clot by hand, and the rv effusion became a much larger hole.The surgeon was able to stop the bleeding and safely place the patient on bypass.Two hours after the initial injury was identified, the repair in the rv was successful, the upgrade of the originally planned biv icd was completed, and the patient survived the procedure.It was noted that the patient's ventricle was ''not normal'' and confirmed with the physician that this was not caused by laser sheath misuse; the thought was that the lead was outside the wall of the heart, and it is not believed that the glidelight caused the tear.

• 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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 9466370
• MDR Text Key: 177006440
• Report Number: 1721279-2019-00217
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• 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: 01/01/2005,11/26/2019

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: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• 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
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/13/2019
• 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: 71 YR
• Patient Weight: 80