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

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

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 01/01/2023

Event Type  Death  

Event Description

A philips representative became aware on (b)(6) 2023 that "last month" a patient died after a lead extraction procedure.Although they could open the chest and stabilize the patient and he could be released to the station, after three days his general circumstance went worse and worse and ended up in the patient's death.During the procedure they could not detect any damage and therefore danger for the patient.But coming to the end of the procedure the patient suddenly had a blood (pressure) drop and started with patient saving process.Spectranetics is not the manufacturer nor importer of the above mentioned devices used in the lead extraction procedure.The manufacturer of these medical devices is cook medical.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LIBERATOR LOCKING STYLET
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): COOK INC
• MDR Report Key: 17488299
• MDR Text Key: 320680429
• Report Number: MW5120997
• 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: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1