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

Catalog Number LR-NES001

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

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)

Event Date 09/12/2019

Event Type  Death  

Manufacturer Narrative

Product code: dxe.Pma/510(k): k961992.(b)(4).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

As reported to customer relations via phone conversation, "this was a highly complex case.The patient had an ef (ejection fraction) of 10% and an enlarged heart.The ep physician went in with the femoral approach to grab the coronary sinus lead (and in doing so) the physician also grabbed the right ventricle lead.The physician did not notice that he grabbed both leads together.When the physician started to pull-down to try to remove the coronary sinus lead, he felt a tug-back.The coronary sinus lead would not release when tugged.It was free in the pocket area, but when tugged, it would not release.When the physician pulled to remove the lead, it would not move.Then the physician enlarged the cine` screen and at that time, the physician noticed that both leads were entrapped in the needles eye snare (lr-nes001).The lead number is 6947 medtronic dual-coil lead.When the physician pulled on both leads, the patient¿s blood pressure started to go down.The doctor then requested the anesthesiologist look at the tee (transthoracic echocardiograph) image and the anesthesiologist noticed a small tear.At this time, the ep physician undid the needles eye snare and released both leads.The ep physician went back in and just grabbed the coronary sinus lead and removed the lead.At this point, the surgeon came in and noticed the patient¿s blood pressure was in the range of 35 to 40.Then, the ep physician started to perform cpr.The surgeon scrubbed-in and had the patient¿s chest cavity opened within a few minutes.When the surgeon opened the patients chest cavity, he noticed the svc (superior vena cava) wall had a tear.The surgeon could not repair the tear in time to save the patient.The patient died at around 6:00pm on (b)(6) 2019.With discussion with both ep physician and surgeon, they came to the conclusion that the svc coil of the lead had torn the svc wall when the ep physician pulled on the lead.The needles eye snare (lr-nes001) did not come in contact with the patient's svc (superior vena cava) wall.".

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: h6- ec method code desc - 1: device not returned (4114) h6- ec results code desc - 1: changed to no findings available (3221) h6- ec conclusions code desc - 1: changed to known inherent risk of device (22) h10- added summary of investigation investigation-evaluation: device was not returned to cvi, therefore a physical investigation could not be performed.The complaint/event entered into trackwise: "lateral tear in svc.Patient death." the device history record (dhr) could not be reviewed due to the lot of the device was unknown.The complaint type will be monitored, tracked and trended in the complaint handling and post market surveillance processes at cvi.The risk assessment will be qera 200617.1 and will be entered within the complaint summary tab of trackwise.Per ifu (d00078680 rev002): "catheter/lead removal devices should be used only by physicians knowledgeable in the techniques and devices for catheter/lead removal" and "potential adverse events.¿.Death".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

As reported to customer relations via phone conversation, "this was a highly complex case.The patient had an ef of (b)(4) and an enlarged heart.When the physician performed the open heart, there was a lateral svc tear.The ep physician went in with the femoral approach to grab the coronary sinus lead (and in doing so) the physician also grabbed the right ventricle lead.The physician did not notice that he grabbed both leads together.When the physician started to pull-down to try to remove the coronary sinus lead, he felt a tug-back.The coronary sinus lead would not release when tugged.It was free in the pocket area, but when tugged, it would not release.When the physician pulled to remove the lead, it would not move.Then the physician enlarged the cine` screen and at that time, the physician noticed that both leads were entrapped in the needles eye snare.The lead number is 6947 medtronic dual-coil lead.When the physician pulled on both leads, the patients blood pressure started to go down.The doctor then requested the anesthesiologist look at the tee image and the anesthesiologist noticed a small tear.At this time, the ep physician undid the needles eye snare and released both leads.The ep physician went back in and just grabbed the coronary sinus lead and removed the lead.At this point, the surgeon came in and noticed the patients blood pressure was in the range of 35 to 40.Then, the ep physician started to perform cpr.The surgeon scrubbed-in and had the patients chest cavity opened within a few minutes.When the surgeon opened the patients chest cavity, he noticed the svc wall had a tear.The surgeon could not repair the tear in time to save the patient.The patient died at around 6:00pm on (b)(6) 2019.With discussion with both ep physician and surgeon, they came to the conclusion that the svc coil of the lead had torn the svc wall when the ep physician pulled on the lead.The needles eye did not come in contact with the patient's svc wall.".

• Brand Name: LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION
• Type of Device: EMBOLECTOMY CATHETER
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 9172667
• MDR Text Key: 161726763
• Report Number: 2522007-2019-00019
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LR-NES001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2019
• Supplement Dates Manufacturer Received: 09/12/2019
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 55 YR