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

Model Number 518-019

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

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

Event Date 07/15/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A lead extraction procedure commenced to remove a right atrial (ra), right ventricular (rv) and a left ventricular (lv) lead due to cied system/pocket infection.Spectranetics lead locking devices (llds) were inserted into each of the leads to provide traction to aid in extraction.The rv lead was extracted successfully with the use of spectranetics 14f and 16f glidelight laser sheaths and a spectranetics 13f tightrail rotating dilator sheath.Efforts were focused on ra lead removal using a 14f glidelight device.Prior to ra lead removal, the physician switched efforts to removal of the lv lead with the 14f glidelight device, then back to the ra lead using the 14f glidelight device.During use of the 14f glidelight device while attempting ra lead extraction, the patient's blood pressure dropped and a pericardial effusion was seen.Rescue efforts began, including pericardiocentesis, delivery of blood products, and cpr.A sternotomy followed with a right atrial perforation discovered; this area was successfully repaired.The patient survived the procedure.This report captures the lld providing traction to the ra lead and an ra perforation occurred, requiring intervention.There is no alleged malfunction of any spectranetics device in use during the procedure.

• 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: 12308976
• MDR Text Key: 266096278
• Report Number: 1721279-2021-00147
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: (01)00813132023010(17)230414(10)FLC21D12A
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K990713
• 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: 07/15/2021

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 Expiration Date: 04/14/2023
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC21D12A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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 4194 LV LEAD; MEDTRONIC 5594 RA PACING LEAD; MEDTRONIC 6944 RV PACING LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 73