MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION 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 06/20/2023

Event Type  Injury  

Manufacturer Narrative

B6): relevant tests/laboratory data unk.D4): device lot, expiration date unk.Partial udi populated.H3): the device was discarded, thus no investigation could be completed.H4): device manufacture date unk because lot number unk.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) and a right ventricular (rv) lead due to cied system/pocket infection, with plans to implant an abbott vascular aveir leadless pacemaker system.The implantation was completed and tested successfully.Due to the patient''s age and fragile state, it was decided to not insert a transesophageal echocardiography (tee) probe for the lead extraction portion of the procedure.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Using a spectranetics 14f glidelight laser sheath on the rv lead, advancement was made into the right atrium when the rv lead came free.As the rv lead was being removed through the glidelight, it became entangled with the ra lead, causing the ra lead tip to dislodge from the right atrial appendage.Once the rv lead was completely removed, efforts focused on full removal of the ra lead.Using the 14f glidelight, smooth advancement was made to the superior vena cava (svc) region, and then, using traction, the physician began to pull the lead from the heart.The lead became stuck in the subclavian region, but with additional lasing, the ra lead came free.The leadless pacemaker was again tested successfully, and the pocket was closed.As the patient was just outside the or, being transferred into recovery, her blood pressure dropped dramatically.She was transferred back to the or, a tee probe was placed, and a pericardial effusion was detected in the right atrium (suspected ra perforation).A pericardiocentesis was successfully performed with no additional intervention required.The patient was stabilized and survived the procedure.This report captures the lld 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: 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: 17274322
• MDR Text Key: 318551319
• Report Number: 1721279-2023-00111
• Device Sequence Number: 1
• Product Code: DRB
• 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: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: ABBOTT 1948 RA PACING LEAD; ABBOTT VASCULAR AVEIR LEADLESS PACEMAKER; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE IN RV LEAD; ST. JUDE MEDICAL 2088TC RV PACING LEAD
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 90 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White