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

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

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove two previously capped leads, a right ventricular (rv) and a right atrial (ra) lead, due to infection.The physician used spectranetics 14f and 16f glidelight laser sheaths, a spectranetics tightrail rotating dilator sheath and cook medical liberator locking stylets within each lead (being used for traction).The physician removed the ra lead first, which reportedly created a hole in the heart.A pericardia! effusion was noted and the pericardium filled with blood.Imaging of the cardiac silhouette showed blood around the heart and the blood pressure dropped.The physician made a sub-xiphoid incision and a drain was placed.The right atrium injury clotted and healed itself.The patient was given blood and blood pressure returned to normal.The procedure was completed with both leads being successfully removed.It was reported that the patient is doing well.Spectranetics is not the manufacturer nor importer of the above mentioned cook medical liberator locking stylet.Cook medical is the manufacturers for this device.Please do not hesitate to reach out to us if we can assist you further.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: 17530339
• MDR Text Key: 321084229
• Report Number: MW5137258
• 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: 02/02/2021

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Patient Age: 78 YR