MAUDE Adverse Event Report: SPECTRANETICS CORPORATION LLD EZ 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 09/21/2023

Event Type  Injury  

Manufacturer Narrative

H3): the device was discarded, thus no investigation could be completed.H6): cardiac perforation is a known risk of complication with use of the lld 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) lead due to lead failure.A right ventricular (rv) and a left ventricular (lv) were present in the patient as well, but were not targeted for extraction.A spectranetics lead locking device (lld ez) was inserted into the ra lead to provide traction.Using a spectranetics glidelight laser sheath, advancement was made past the subclavian vein, where progress stalled.A spectranetics 11f tightrail rotating dilator sheath was used next, which made steady progress, and the lead released.Approximately 20-30 seconds later, a small pericardial effusion was detected via transesophageal echocardiography (tee).An ra perforation was suspected because the patient''s chest was not opened and an injury location could not be confirmed.Rescue efforts began, including pericardiocentesis.The re-implantation of a new lead was successful, and the patient survived the procedure.This report captures the lld ez providing traction to the ra lead when the suspected perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• Brand Name: LLD EZ LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): 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: 17941073
• MDR Text Key: 325750547
• Report Number: 3007284006-2023-00037
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)250829(10)FLP23H28A
• 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: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• 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: FLP23H28A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2023
• 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: MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 6935 RV PACING LEAD; MEDTRONIC LV LEAD MODEL UNK; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White