MAUDE Adverse Event Report: COOK MEDICAL COOK MEDICAL LIBERATOR LOCKING STYLET; STYLET, CATHETER

Model Number 5386

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

Patient Problem Perforation (2001)

Event Type  Injury  

Event Description

A philips representative was made aware of a lead extraction procedure to remove 3 leads that took place on (b)(6) 2021.The physician was removing the last right ventricular lead, model 5386, implanted (b)(6) 1991.The lead was extracted and a right ventricular perforation was discovered.The surgeon performed a sternotomy and successfully repaired the perforation.During the procedure, the physician was using a spectranetics 14f glide light laser sheath, a spectranetics visisheath dilator sheath, and a cook medical liberator locking stylet for traction.There is no indication that either the glidelight or visisheath devices reached the area of injury.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: COOK MEDICAL LIBERATOR LOCKING STYLET
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): COOK MEDICAL
• MDR Report Key: 17535780
• MDR Text Key: 321043842
• Report Number: MW5142674
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 5386
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1