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 Sepsis (2067); Cardiac Perforation (2513); Heart Failure/Congestive Heart Failure (4446)

Event Type  Death  

Manufacturer Narrative

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

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.A total of (7) deaths were recorded by the study, 3 occurred during procedures and the remaining 4 happened post operatively.In summary: (3) patients and (3) deaths.Lacerations of the atrium/ ventricle and died despite urgent surgical repair.(4) patients and (4) deaths, the four patients died of the following causes within 30 days after tle: one of multiple organ dysfunction syndrome, one of severe heart failure, and two of septic shock.

Manufacturer Narrative

Complaint could only be confirmed by testimony/literature.The complaint/event that was entered and reported into trackwise: "intra-procedural death".Per the literature/complaint information: "retrospectively identified all patients who underwent tle at institution between march 2013 and january 2021.This population was divided into the following two groups based solely on age: octogenarians and non-octogenarians.These two groups were compared on the basis of several characteristics and clinical outcomes.(3) patients and (3) deaths.Lacerations of the atrium/ ventricle and died despite urgent surgical repair." 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.A risk assessment will be performed in the complaint summary tab within 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.

• 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: 13524915
• MDR Text Key: 285565996
• Report Number: 2522007-2022-00003
• 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: 05/05/2022

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: 05/06/2022
• 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): Death