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

Catalog Number LR-NES001

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

Patient Problem Cardiac Tamponade (2226)

Event Date 02/24/2021

Event Type  Injury  

Manufacturer Narrative

Pma/510(k): k961992.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 literature finding specifies a major adverse event attributed to the lead extraction needle's eye femoral snare and workstation (lr-nes001) for two patients during a study by bracke, et al.The two patients developed pericardial tamponade from atrial perforation after successful lead removal.Both perforations of the atrial wall occurred after extracting the lead with a needle¿s eye snare and the patients were immediately operated on and recovered completely later.

Manufacturer Narrative

This report includes information known at this time.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

This literature finding specifies a major adverse event attributed to the lead extraction needle's eye femoral snare and workstation (lr-nes001) for two patients during a study by bracke, et al.The two patients developed pericardial tamponade from atrial perforation after successful lead removal.Both perforations of the atrial wall occurred after extracting the lead with a needle¿s eye snare and the patients were immediately operated on and recovered completely later.

• 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
• MDR Report Key: 11554745
• MDR Text Key: 241788373
• Report Number: 2522007-2021-00012
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 10827002265179
• UDI-Public: (01)10827002265179(17)140331(10)N97422
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

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 Expiration Date: 03/31/2014
• Device Catalogue Number: LR-NES001
• Device Lot Number: N97422
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention