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

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

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

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

Cardiac perforation is a known risk of 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 right ventricular (rv) lead, implanted for 264 months, and an ra and rv lead, implanted for 300 months, due to non function.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.While extracting the rv lead (implanted for 264 months) using a spectranetics glidelight laser sheath and applying traction, the lead''s helix fixation broke free, releasing the rv lead.At that time, the patient''s blood pressure dropped and a pericardial effusion was detected via transesophageal echocardiography (tee).An rv perforation was suspected.A pericardiocentesis was performed until the bleeding clotted off and the blood pressure was restored.All leads were removed from the patient.The patient survived, and was reported as stable post-procedure and upon check-in a few days later.This report captures the lld 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: 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 ; 719447-246
• MDR Report Key: 16432724
• MDR Text Key: 310129140
• Report Number: 1721279-2023-00027
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/23/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 4053 RA PACING LEAD; BOSTON SCIENTIFIC 4054 RV PACING LEAD; BOSTON SCIENTIFIC 438-07 RA PACING LEAD; BOSTON SCIENTIFIC 438-07 RV PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Ethnicity: Non Hispanic
• Patient Race: White