MAUDE Adverse Event Report: COOK VANDERGRIFT INC LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION; EMBOLECTOMY CATHETER

Catalog Number LR-NES001

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

Patient Problems Cardiac Arrest (1762); Atrial Perforation (2511)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

Product code: dxe.Concomitant products: curved femoral introducer sheath set (lr-css16), evolution® rl shortie controlled-rotation dilator sheath set-11fr (lr-evn-sh-11.0), evolution® rl controlled-rotation dilator sheath set -13fr (lr-evn-13.0-rl), lead clippers (lr-clp001) , liberator® beacon® tip locking stylet (lr-ofa01) , one-tie® compression coil (lr-ote-n) , steadysheath® evolution® shortie tissue stabilization sheath (lr-tss-sh-11.0) , steadysheath® evolution® tissue stabilization sheath (lr-tss-13.0).Pma/510(k): k961992.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available or upon completion of investigation.

Event Description

It was reported that on (b)(6) 2019 patient (b)(6) for study 16-04 underwent a lead extraction procedure in which the patient experienced a cardiac avulsion or tear.The patient went into cardiac arrest.Her chest was opened, and cardiac massage was performed until she could be placed on cardiopulmonary bypass.The atrium was repaired, and the leads were removed while the patient was on bypass.The patient noted to have left ventricular dysfunction.A heart cath was performed to remove an embolus thought to be from the atrial debris.The femoral artery (where cardiopulmonary bypass cannulation was attempted) had to be surgically repaired.Due to bleeding from the femoral artery the patient received packed red blood cells.The patient was placed on ecmo (extracorporeal membrane oxygenation) and transferred to the icu (intensive care unit).The patient was discharged from the hospital on (b)(6) 2019.No further events have been reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: h6- ec method code desc - 1: device not returned (4114).H6- ec results code desc - 1: changed to no findings available (3221).H6- ec conclusions code desc - 1: changed to known inherent risk of device (22).H10- added summary of investigation.Investigation-evaluation: no device was returned on this complaint, therefore a physical investigation could not be performed.The complaint/event entered into trackwise: "patient experienced a cardiac avulsion or".The device history record(dhr) was not reviewed due to the lot is unknown.Adverse physiological response is a known failure mode of this device.The complaint mode will be tracked, trended and monitored per cvi's post market surveillance and complaint handling processes.The risk assessment will be performed via qera (b)(4) and documented in the complaint summary tab of trackwise.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

It was reported that on 12aug2019 patient (b)(6) for study 16-04 underwent a lead extraction procedure in which the patient experienced a cardiac avulsion or tear.The patient went into cardiac arrest.Her chest was opened, and cardiac massage was performed until she could be placed on cardiopulmonary bypass.The atrium was repaired, and the leads were removed while the patient was on bypass.The patient noted to have left ventricular dysfunction.A heart catheterization was performed to remove an embolus thought to be from the atrial debris.The femoral artery (where cardiopulmonary bypass cannulation was attempted) had to be surgically repaired.Due to bleeding from the femoral artery the patient received packed red blood cells.The patient was placed on ecmo (extracorporeal membrane oxygenation) and transferred to the icu (intensive care unit).The patient was discharged from the hospital on 16oct2019.No further events have been reported.

• Brand Name: LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION
• Type of Device: EMBOLECTOMY CATHETER
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 9412522
• MDR Text Key: 171555635
• Report Number: 2522007-2019-00024
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: K961992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LR-NES001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 80