MAUDE Adverse Event Report: COOK VASCULAR COOK 9F EVOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Device Problems Entrapment of Device (1212); Use of Device Problem (1670)

Patient Problems Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Type  Injury  

Event Description

It was reported that a lead extraction procedure commenced to remove two leads: a right atrial (ra) lead and a right ventricular (rv) lead, in order to upgrade to a crt-p system.Spectranetics lead locking devices were placed in both leads.They began with attempt to remove rv lead first using a cook evolution 9f device but progression stalled at the subclavian vein.They then switched their extraction attempt to ra lead but stalled in the same area.They then switched efforts back to the rv lead with use of 9f device and progressed to the superior vena cava (svc) but progression then stalled.They switched to the ra lead again and were able to pass through svc but could not remove tip of the ra lead.The patient's blood pressure dropped slightly but recovered using pressors to stabilize the patient.They then changed effort again to removal of the rv lead using a spectranetics 14f glide light laser sheath.They could remove rv lead successfully with counter traction.However, it was difficult to pull the rv lead through the glidelight device, as the lead became stuck within the glide light device.They then lased for one (1) second and completely removed the rv lead/lld and the glidelight device.The patient's blood pressure dropped again at this time, and an effusion was noticed along with cardiac tamponade.Rescue efforts began immediately, including cpr and sternotomy.A tear was discovered in the ra and was repaired successfully.There was an attempt made to remove the ra lead using a 14f glide light device; however the attempt was unsuccessful as the lead reportedly broke away from the electrode due to traction forces.The tip of the ra lead was ultimately removed surgically.The patient survived the procedure and was transferred to icu with an intra-aortic balloon pump.Ni.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: COOK 9F EVOLUTION
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK VASCULAR
• MDR Report Key: 17523333
• MDR Text Key: 321083433
• Report Number: MW5130281
• Device Sequence Number: 1
• Product Code: DRE
• 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