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); Device Embedded In Tissue or Plaque (3165)

Event Date 10/10/2022

Event Type  Death  

Manufacturer Narrative

A portion of the device was discarded, and a portion remained in the patient, thus no investigation could be completed.H6): cardiac perforation is a known risk of complication with use of the lld.Although lld cut/cap within a lead is a known risk of complication with use of the lld, the physician did not attempt to unlock the lld from the ra lead prior to cutting and capping it.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 ventricular (rv), a right atrial (ra) and a left ventricular (lv) lead due to bacteremia, and cied system/pocket infection.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Using a spectranetics 16f glidelight laser sheath, the rv lead was successfully removed.While attempting removal of the ra lead and with the glidelight in the svc region, the ra lead released with traction.The patient''s condition declined and rescue efforts began, including bypass and sternotomy.An ra perforation was discovered and was successfully repaired.The atrial wall was very thin and it was thought that due to the ra lead being a fixed screw lead, the damage was caused when traction was applied and the ra tip released.The physician did not remove the ra or lv leads and did not attempt to unlock the llds from the leads; both leads and llds were cut and capped and remained in the patient (mdr 1721279-2022-00186 lv lead/lld).The patient was transferred to the icu in critical condition; however, on (b)(6) 2022 the patient died.This report captures the lld providing traction to the ra lead when the perforation occurred and the ra lead/lld were cut and capped and remained in the patient.The perforation required intervention but resulted in death.There was no alleged malfunction of any spectranetics devices 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): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 15722760
• MDR Text Key: 303020712
• Report Number: 1721279-2022-00187
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023014
• UDI-Public: (01)20813132023014(17)240324(10)FLC22C17A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990713
• 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: 11/03/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2024
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC22C17A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2022
• Initial Date FDA Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• 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 0184 RV PACING LEAD; BOSTON SCIENTIFIC 4469 RA PACING LEAD; BOSTON SCIENTIFIC 4524 LV LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES
• Patient Outcome(s): Required Intervention; Death; Life Threatening
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White