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 Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Type  Injury  

Manufacturer Narrative

¿blank fields on this form indicated the information is unknown, unchanged, or unavailable.¿ , fill in the common name/product code/510k information if needed (see example below what will be entered ¿ be sure to confirm specific codes to the specific product that is called out within section d: suspect medical device ), ¿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.Blank fields on this form indicate the information is unknown, unchanged, or unavailable¿ ¿g5 - pma/510(k): k961992.

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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.G5 - pma/510(k): k961992.This was a literature complaint and 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, other than by the customer's testimony.The complaint/event that was entered and reported within trackwise: "tricuspid regurgitation without need for immediate intervention." per literature, "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." 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.

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: 17864709
• MDR Text Key: 324848351
• Report Number: 2522007-2023-00019
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

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: 10/03/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2024
• 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