MAUDE Adverse Event Report: MEDTRONIC MEXICO BIO-MEDICUS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number CB96670-019

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

Patient Problem Hematoma (1884)

Event Date 08/12/2022

Event Type  Injury  

Event Description

Medtronic received information via literature regarding surgical procedures for patients with retroperitoneal sarcoma (rps), that involve the inferior vena cava (ivc), the abdominal aorta and in some cases both vessels were involved.All data was collected from multiple centers between 12 september 2018 and 26 may 2021.The study population included 16 patients (predominantly female), cortiva coated medtronic cannulae were used in the right femoral veins and uncoated medtronic cannulae were used in the right internal jugular veins (rijv) (lot numbers not provided).Among all patients, no deaths occurred.Among all patients, adverse events included: an inappropriately placed venous return cannula which resulted in a large volume of blood infused into the right pleural cavity.This necessitated resuscitation and involved a median sternotomy to facilitate vein repair, and the patient recovered.The other adverse event that was observed was a groin haematoma which required drainage.Based on the available information, these adverse events may have been attributed to medtronic products.Among all patients, no device malfunctions occurred.

Manufacturer Narrative

Literature citation authors: damian wong, joe hockley, simon parys, rupert hodder, shirley jansen, and mark newman journal name: european journal of vascular and endovascular surgery year: 2022 issue: 64 title of article: current technology venous-venous bypass improves the safety of resection of sarcoma and benign retroperitoneal tumours involving the inferior vena cava literature reference: 10.1016/j.Ejvs.2022.07.049 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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BIO-MEDICUS
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17562976
• MDR Text Key: 321311374
• Report Number: 9612164-2023-03732
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K180453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2023

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: CB96670-019
• Device Catalogue Number: CB96670-019
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/17/2023
• 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
• Patient Sex: Female