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

Catalog Number	LR-NES001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.This report represents patient #2.
Additional 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 or Problem 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 (b)(6), 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.This report represents patient #2.

• Brand Name: LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION
• Common Device Name: DXE CATHETER, EMBOLECTOMY
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 11555352
• Report Number: 2522007-2021-00013
• Device Sequence Number: 11719971
• Product Code: DXE
• UDI-Device Identifier: 10827002265179
• UDI-Public: (01)10827002265179(17)140331(10)N97422
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K961992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention