MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number 518-062

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

Patient Problems Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 10/22/2021

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead due to lead failure.A right atrial (ra) lead was also in the patient but was not targeted for extraction.A spectranetics lead locking device (lld) was inserted into the rv lead to provide traction.Among other tools, the physician was using a spectranetics 14f glidelight laser sheath to attempt extraction of the rv lead.Binding was noted in the subclavian, innominate and superior vena cava (svc) regions.While the glidelight was lasing in the right atrium (ra) and traction was being applied by the lld, the patient's blood pressure dropped and a baseline effusion started to grow.Rescue efforts began, including pericardiocentesis (unsuccessful) and a subxiphoid window.A sternotomy was not performed in this event so an injury location could not be confirmed, but an ra perforation was suspected to be the cause of the effusion.The effusion was drained via the subxiphoid window and a drain was placed in the pericardium.The extraction continued, the rv lead was successfully extracted and re-implantation with a new lead was completed.The subxiphoid window was closed with a drain left in place, the procedure was completed, and the patient survived.This report captures the lld providing traction when the suspected ra perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

The device was discarded, thus no investigation could be completed.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 12824111
• MDR Text Key: 280892393
• Report Number: 1721279-2021-00220
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• 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?: No
• Date Manufacturer Received: 10/22/2021
• 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
• Treatment: MEDTRONIC 5086 RA PACING LEAD; MEDTRONIC 5086 RV PACING LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male