MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION 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 04/27/2023

Event Type  Injury  

Manufacturer Narrative

Patient's weight unk.Other relevant history unk.The device was not returned, thus no investigation could be completed.Cardiac perforation is a known complication with use of the lld device.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to needing a system that was mri compatible (leads had been implanted 19 years).Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Attempting extraction of the rv lead, a spectranetics 14f glidelight laser sheath was easily advanced to the right atrium, but progress stalled due to a binding site between the rv and ra leads.Efforts switched to the ra lead, and advanced only up to the same binding site.A spectranetics 11f tightrail rotating dilator sheath was then used to cut through the calcified lead on lead binding, and was able to advance near the tip of the ra lead.However, the lead tip began to stretch, so the physician switched back to the glidelight to avoid snapping the tip.Using countertraction with the lld, the physician gently pulled the ra lead back into the glidelight, while activating the glidelight with no forward advancement.The ra lead became partially freed, but was still attached, either by tissue or a fragment of the lead not visible by fluoroscopy.Using transoral-esophageal echocardiography (toe), it was confirmed there was no inversion of the ra when countertraction was applied, and that the glidelight was in the middle of the ra and not up against any structures, as to not create injury.Countertraction continued, with the lead approximately 3-5 cm within the glidelight, and the lead finally released.Approximately 1-2 minutes after the ra lead was removed, the patient''s blood pressure dropped and toe detected a pericardial effusion.Rescue efforts began immediately, including sternotomy.A 1-2 cm linear perforation above the right atrial appendage was discovered and repaired.The rv lead was successfully extracted post-sternotomy with use of the glidelight.The patient survived the procedure.This report captures the lld providing traction to the ra lead when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• Brand Name: LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 16987526
• MDR Text Key: 315794412
• Report Number: 1721279-2023-00081
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)250112(10)FLP23A11A
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2023

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
• Device Lot Number: FLP23A11A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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: BOSTON SCIENTIFIC 4592 RA PACING LEAD; MEDTRONIC 4092 RV PACING LEAD; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE IN RV LEAD
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White