MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number LF1737

Device Problems Energy Output Problem (1431); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 05/19/2014

Event Type  Death  

Event Description

An attorney alleged a deficiency against the device.The product was used to seal a pulmonary artery.After the surgery was completed, it was noted that there was bleeding from a pulmonary artery.Tachosil, ligature thread, and a ligasure device were all used in controlling the bleeding.The 5mm diameter pulmonary artery was ligated with a thread, sealed with ligasure once, and dissected.The patient was closed up and repositioned, when blood was noticed mixed in the drain.The chest was reopened where there was heavy bleeding, and the patient went into cardiac arrest despite reoperation, and died.The artery in question appeared to still be circular in shape, even after ligasure use, and the suture wasn't found.It was reported that after implant, the patient experienced the seal reopening, heavy bleeding, cardiac arrest, and death.Post-operative patient treatment included reopening of the surgical sight.Information received indicates the patient is now deceased, due to heavy bleeding that lead to cardiac arrest.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 17882713
• MDR Text Key: 325060435
• Report Number: 1717344-2023-01243
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521181571
• UDI-Public: 10884521181571
• Combination Product (y/n): N
• PMA/PMN Number: K133338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/05/2023

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 Model Number: LF1737
• Device Catalogue Number: LF1737
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2023
• 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
• Patient Outcome(s): Required Intervention; Death