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

Catalog Number LR-NES002

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

Patient Problems Cardiac Tamponade (2226); Embolism/Embolus (4438)

Event Date 01/18/2022

Event Type  Injury  

Event Description

This complaint was identified in a retrospective literature review on transvenous lead extraction (tle) conducted between march 2013 and january 2021.The study population was separated into two groups based solely on age: octogenarians and non-octogenarians.These two groups were compared on the basis of several characteristics and clinical outcomes.During lead extraction via femoral approach by the cook needle's eye snare.Summary of identified complications: (1) pulmonary embolism treated by surgical thrombectomy and (1) paradoxical embolism treated by successful thrombolytic therapy.Both of the patients recovered.(8) complications in (8) patients: cardiac tamponade in eight different individuals were all successfully treated with pericardiocentesis.All of the patients recovered.

Manufacturer Narrative

Manufacturer Narrative

Investigation: the device history record (dhr) was not able to be reviewed because the lot of the device was unknown.The complaint mode will be monitored, tracked, and trended per cvi's complaint handling and post market surveillance processes.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.

• Brand Name: LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION
• Type of Device: DXE CATHETER, EMBOLECTOMY
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer (Section G): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: brian johnston ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 13524794
• MDR Text Key: 289679823
• Report Number: 2522007-2022-00002
• 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: Other,Foreign,Literature,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2022

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-NES002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 01/18/2022
• Supplement Dates FDA Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention