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 Tamponade (2226)

Event Date 02/06/2024

Event Type  Injury  

Event Description

Severity as considered by the doctor: hospitalization or extension of hospitalization period.Related products: lr-evn-13.0-rl/n197583, lr-ofa01/n198260, lr-ote-n/n192484.Defect occurrence status: during removing the ra lead that was implanted in the right anterior chest in 1987, while the physician grasped the ring electrode part of the ra lead with lr-nes001 approached from subclavian vein and attempted to remove the adhesions of the lead with the lr-evn-13.0-rl inserted from the lead insertion site (subclavian vein) pulling it toward the femoral side, the tip of the ra lead fell toward the femoral side and it appeared that the tip of the lead had come off.When dr.(b)(6), who was acting as his assistant, attempted to grasp it again with lr-nes001, the patient's blood pressure dropped.The patient was monitored for a while, but his blood pressure did not return to normal and continued to drop gradually, so the surgeon, dr.(b)(6), requested assistance from a cardiovascular surgeon.A cardiovascular surgeon performed hemostasis through thoracotomy.Dr.(b)(6) said that there were two holes, one at the svc-ra confluence and the other at the base of the right atrial appendage.He believed the right atrial appendage was torn when the nes dropped, and the svc-ra confluence may have been torn shortly before the right atrial appendage, but the blood had clotted, so it probably did not occur until the blood pressure dropped.Actions taken in response to defects: after a decrease in blood pressure was observed, transesophageal echocardiography confirmed that pericardial effusion was increasing.As the blood pressure continued to drop gradually, the surgeon, dr.(b)(6), requested the assistance of a cardiovascular surgeon.The cardiovascular surgeon performed open chest hemostasis.A median sternotomy was made, and the patient underwent repair procedures while receiving a blood transfusion.The patient was connected to an autologous blood collection device and then to an artificial heart-lung machine.Patient's condition after additional procedures: the lead was surgically removed and the patient was discharged.

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.D2b ¿ product code: dqxe.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

Past history, constitution, etc.:unknown.The patient has an infection, but the cause is unknown.Severity as considered by the doctor: hospitalization or extension of hospitalization period related products -lr-evn-13.0-rl/n197583 -lr-ofa01/n198260 -lr-ote-n/n192484 defect occurrence status: during removing the ra lead that was implanted in the right anterior chest in 1987, while the physician grasped the ring electrode part of the ra lead with lr-nes001 approached from subclavian vein and attempted to remove the adhesions of the lead with the lr-evn-13.0-rl inserted from the lead insertion site (subclavian vein) pulling it toward the femoral side, the tip of the ra lead fell toward the femoral side and it appeared that the tip of the lead had come off.When dr.(b)(6), who was acting as his assistant, attempted to grasp it again with lr-nes001, the patient's blood pressure dropped.The patient was monitored for a while, but his blood pressure did not return to normal and continued to drop gradually, so the surgeon, dr.(b)(6), requested assistance from a cardiovascular surgeon.A cardiovascular surgeon performed hemostasis through thoracotomy.Dr.(b)(6) said that there were two holes, one at the svc-ra confluence and the other at the base of the right atrial appendage.He believed the right atrial appendage was torn when the nes dropped, and the svc-ra confluence may have been torn shortly before the right atrial appendage, but the blood had clotted, so it probably did not occur until the blood pressure dropped.Actions taken in response to defects: after a decrease in blood pressure was observed, transesophageal echocardiography confirmed that pericardial effusion was increasing.As the blood pressure continued to drop gradually, the surgeon, dr.(b)(6), requested the assistance of a cardiovascular surgeon.The cardiovascular surgeon performed open chest hemostasis.A median sternotomy was made, and the patient underwent repair procedures while receiving a blood transfusion.The patient was connected to an autologous blood collection device and then to an artificial heart-lung machine.Patient's condition after additional procedures: the lead was surgically removed and the patient was discharged.

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 was acknowledged but could not be confirmed, other than by the customer's testimony.The complaint/event that was entered and reported within trackwise: "cardiac tamponade." per complaint entry: " dr.(b)(6): there were two holes, one at the nameless vein-svc confluence and the other at the base of the right atrial appendage.He believed the right auricle was torn when the nes dropped, and the svc-ra confluence may have been torn shortly before the right atrial appendage, but the blood had clotted, so it probably did not occur until the blood pressure dropped.When the liberator came out of the lead midway through, the extraction device was passed through the lead lumen with nothing in it, which probably caused damage.I don't know what device caused the damage.The cardiovascular surgeon performed open chest hemostasis.A median sternotomy was made, and the patient underwent repair procedures while receiving a blood transfusion.The patient was connected to an autologous blood collection device and then to an artificial heart-lung machine.Patient's condition after additional procedures: the lead was surgically removed, and the patient was discharged." the device history record (dhr) was reviewed.There were no signs that the device was nonconforming or that the device was not manufactured to current specifications.This complaint mode will be tracked, trended and monitored in cvi complaint handling and post market surveillance procedures.A risk assessment will be performed within the complaint summary tab of trackwise.G5 ¿ pma/510(k): k961992.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 VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: timothy vogel ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 18663417
• MDR Text Key: 334833765
• Report Number: 2522007-2024-00002
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2024

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: N195486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2023
• 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
• Treatment: G23747/LR-EVN-13.0-RL/N197583; G26550/ LR-OFA01/N198260; G31929/LR-OTE-N/N192484
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male