MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EDGE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number SDK4190-FT

Device Problems Application Program Problem (2880); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/14/2024

Event Type  Death  

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.

Event Description

According to the reporter, during the procedure, after registration while attempting to navigate out to the lesion, the physician experienced moderate bleeding.The bleeding was observed followed the introduction of the catheter into the peripheral airway.The physician removed the catheter and flushed with saline and epinephrine to control the bleeding. after bleeding was controlled, the catheter was put back in.Shortly after, the anesthesiologist noted a sudden drop in blood pressure of the patient resulting in a code and chest compressions twice to stabilize. the physician pulled the catheter and scope.Patient did not respond to anesthesia interventions.The patient was stabilized and brought to the intensive care unit (icu).The superdimension portion of the case was not completed and was not completed by other means.The patient had heart failure with the induction of sedation.The patient has deceased.The patient's death has no relationship with the device issue and stemmed from anesthesia event most likely from heart failure from sedation.

• Brand Name: EDGE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18892090
• MDR Text Key: 337510483
• Report Number: 3004962788-2024-00015
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 10884521581388
• UDI-Public: 10884521581388
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SDK4190-FT
• Device Catalogue Number: SDK4190-FT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• 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): Death; Hospitalization; Required Intervention
• Patient Sex: Female