MAUDE Adverse Event Report: COOK VASCULAR COOK LIBERTOR; STYLET, CATHETER

Device Problem Use of Device Problem (1670)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 06/14/2019

Event Type  Injury  

Event Description

In accordance with title 21 part 803, subpart b, 803.22(b)(2), this letter is to notify and provide you the information spectranetics (a division of philips) received on (b)(6) 2019 related to a reported adverse event during a lead extraction procedure.The procedure date was (b)(6) 2019.Although spectranetics devices (14f glidelight and 33cm medium visisheath) were in use during the patient procedure, the patient's blood pressure had dropped while manual traction was being applied with the use of a cook liberator device as the traction platform being used.A right ventricular (rv) apex injury was discovered; the patient underwent sternotomy, and the repair was successful with the patient surviving the procedure.14fr glidelight with m33 visisheath was used to get down to the rv apex.Manual traction was held on the lead, and the tip of the laser approximately 1-2cm from the tip of the lead.The lead released after about a minute of traction.After 1 minute, the blood pressure started to drop.Tee confirmed an effusion.Ct surgeon was paged, within minutes arrived, team opened chest, repaired hole in the rv apex within less than 10 minutes from arrival.Further detail received from rep: cook liberator being used as traction platform.(b)(6) was applying manual traction trying to get the tip to release from the rv apex when the avulsion occurred.Dr.Andriulli stopped use of the glidelight and visisheath devices 1-2 cm from the tip of the lead, then applied manual traction when the lead released.Ni this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: COOK LIBERTOR
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): COOK VASCULAR
• MDR Report Key: 17526072
• MDR Text Key: 321133260
• Report Number: MW5133012
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1