MAUDE Adverse Event Report: SPECTRANETICS CORPORATION LLD #2 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 12/13/2023

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 ventricular (rv) lead due to high impedance.A spectranetics lld #2 lead locking device (lld #2) was inserted into the lead to provide traction.Beginning with a soectranetics 16f glidelight laser sheath, progress was made past the lead's' proximal coil in the superior vena cava (svc), then stalled.Switching to a spectranetics 13f tightrail rotating dilator sheath, advancement was made down the svc when suddenly, the lead tip freed, the patient's blood pressure dropped quickly, and a pericardial effusion was detected via intracardiac echocardiography (ice).Rescue efforts began immediately, including pericardiocentesis and administration of medications and fluids.Although the patient's blood pressure improved, almost a liter of blood was removed over the course of 20 minutes, and there was no sign of the effusion stopping.A sternotomy followed, and a 4-5 mm perforation at the rv apex was discovered and repaired.The patient survived the procedure.This report captures the lld #2 providing traction to the rv lead when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• Brand Name: LLD #2 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: 18455076
• MDR Text Key: 332255327
• Report Number: 3007284006-2023-00099
• Device Sequence Number: 1
• Product Code: DRB
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC23K03A
• 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: 10/03/2023
• 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 0295 RV ICD LEAD.; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH.; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native