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 Stroke/CVA (1770)

Event Type  Injury  

Manufacturer Narrative

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

Literature - clinical procedural success was achieved in 126 of 131 patients (96.2%).Complete extraction success was achieved in 246 of 267 targeted leads (92.1%).No patient in our series experienced vascular injury, and in particular there was no tear, perforation, or other apparent damage to the superior vena cava.Four patients experienced a total of 5 major complications (table 3).Three patients developed pericardial effusion requiring drainage.Two strokes occurred during or within 24 hours after the procedure.There were no procedural deaths.Minor complications occurred in 11 of 131 patients (8.4%) (table 3).More than half of these minor complications were an increase in the grade of tricuspid regurgitation without the need for immediate intervention.Most frequently, this was a finding reported on the intraoperative transesophageal echocardiogram without clinical correlation.However, 1 patient required tricuspid valve replacement 5 years after his extraction procedure for right heart failure that could not be adequately managed medically.

• 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: timothy vogel ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 17868697
• MDR Text Key: 324893163
• Report Number: 2522007-2023-00022
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2023

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: 10/04/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other