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 Perforation (2513)

Event Date 10/18/2023

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicated the information is unknown, unchanged, or unavailable.The event is currently under investigation.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.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

Right atrial perforation required immediate open-heart surgery (literature).Occurred after lead extraction.

Event Description

Right atrial perforation required immediate open-heart surgery (literature).Occurred after lead extraction.

Manufacturer Narrative

Blank fields on this form indicated the information is unknown, unchanged, or unavailable.The device was not returned for the complaint; therefore, a physical investigation could not be performed, and the customer's complaint could not be confirmed, but was acknowledged, other than by the customer's testimony.Per literature, a right atrial perforation occurred just after lead extraction that required immediate open-heart surgery, which was caused by the needle eye snare.The complaint/event that was entered and reported within trackwise: "right atrial perforation required immediate open-heart surgery." the device history record (dhr) was unable to be viewed due to the lot number specific to this complaint was unknown.This complaint mode is being monitored, tracked and trended per the cvi post market surveillance and complaint handling processes.A risk assessment will be performed and documented in the complaint summary tab in 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 VASCULAR INC.; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: timothy vogel ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 18072978
• MDR Text Key: 327397097
• Report Number: 2522007-2023-00025
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2024
• 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): Other; Required Intervention