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

Catalog Number LR-NES002

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

Patient Problems Air Embolism (1697); Cardiac Perforation (2513)

Event Type  Injury  

Manufacturer Narrative

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

A literature finding stated that an (b)(6) man with a pocket infection within his left pectoral region was referred to sendai kousei hospital.During his lead extraction procedure, a case of a coronary air embolism secondary to an atrial septal perforation was encountered.Transvenous lead extraction was performed in a hybrid operating room under general anesthesia by dedicated cardiologists and cardiac surgeons, with extracorporeal circulation on standby.The infected pocket was widened and heavily debrided of all inflammatory tissue.The (b)(6)leads were dissected from the adhesions inside the pocket, and the fixation sutures were removed.Due to the age of the leads, a combined superior and femoral approach was implemented to achieve appropriate co-axial alignment of the powered sheath with the targeted leads.Before starting the superior approach, an 18-fr sheath was introduced into the femoral vein, and the femoral approach was attempted using the needle's eye snare.This involved the snare being twisted around the targeted lead using a clockwise or counterclockwise rotation of the snare, initially with a small retriever (13 mm) and later a 20 mm device.Despite several attempts, the lead was never grasped, and during this period, the patient's blood pressure suddenly decreased from 120/70 to 80/50 mm hg accompanied by st-segment elevation that was detected using continuous bedside electrocardiogram monitoring.Transesophageal echocardiography revealed air bubbles and atrial septal perforation.Coronary angiography revealed a right coronary artery air embolism, which was resolved by repeated saline flushes that normalized the blood pressure and st-segment elevation.The risk of a systemic air embolism seemed small, provided the femoral approach using the needle's eye snare was discontinued; therefore, the femoral approach was abandoned.Thereafter, the superior approach using a powered sheath was utilized to successfully extract both leads.The patient was then discharged from the hospital in good health without any requirement for further procedures.

Manufacturer Narrative

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

A literature finding stated that an 82-year-old man with a pocket infection within his left pectoral region was referred to sendai kousei hospital.During his lead extraction procedure, a case of a coronary air embolism secondary to an atrial septal perforation was encountered.Transvenous lead extraction was performed in a hybrid operating room under general anesthesia by dedicated cardiologists and cardiac surgeons, with extracorporeal circulation on standby.The infected pocket was widened and heavily debrided of all inflammatory tissue.The 29-year-old leads were dissected from the adhesions inside the pocket, and the fixation sutures were removed.Due to the age of the leads, a combined superior and femoral approach was implemented to achieve appropriate co-axial alignment of the powered sheath with the targeted leads.Before starting the superior approach, an 18-fr sheath was introduced into the femoral vein, and the femoral approach was attempted using the needle's eye snare.This involved the snare being twisted around the targeted lead using a clockwise or counterclockwise rotation of the snare, initially with a small retriever (13 mm) and later a 20 mm device.Despite several attempts, the lead was never grasped, and during this period, the patient's blood pressure suddenly decreased from 120/70 to 80/50 mm hg accompanied by st-segment elevation that was detected using continuous bedside electrocardiogram monitoring.Transesophageal echocardiography revealed air bubbles and atrial septal perforation.Coronary angiography revealed a right coronary artery air embolism, which was resolved by repeated saline flushes that normalized the blood pressure and st-segment elevation.The risk of a systemic air embolism seemed small, provided the femoral approach using the needle's eye snare was discontinued; therefore, the femoral approach was abandoned.Thereafter, the superior approach using a powered sheath was utilized to successfully extract both leads.The patient was then discharged from the hospital in good health without any requirement for further procedures.

• 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: 12262561
• MDR Text Key: 264971624
• Report Number: 2522007-2021-00024
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

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 Catalogue Number: LR-NES002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 07/12/2021
• Supplement Dates FDA Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR