MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-MEDICUS NG 15 FR VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number 96670-115

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 11/04/2020

Event Type  malfunction  

Event Description

Medtronic received information via literature regarding a retrospective single-center analysis made of children to 16 years of age who underwent corrective cardiac surgery using vertical right axillary minithoracotomy (vramt) over a period of 5 years.All data were collected from a single center between january 2012 and december 2018.The study population included 110 patients (half were female; mean age 2 years).Medtronic bio-medicus femoral venous cannulae were used during the study.Among all patients, no deaths occurred.Among all patients, adverse events included: pneumonia and the need of permanent pacemaker implantation for complete heart block in a patient with complete atrioventricular septal defect (cavsd).Based on the available information the adverse events are not related to the medtronic products.Among all patients, there the following device malfunction occurred; 5 cases of early thrombosis (less than 24 hours) at the cannulation site in the right.Femoral vein in the initial period after starting percutaneous femoral vein cannulation.Retrospectively, it appears that this complication was mostly due to an oversizing of the cannula size.The author stated that since they routinely adopted postoperative prophylactic antithrombotic therapy by unfractionated heparin treatment, these complications have not reoccurred.In patients with a body surface area less than 0.3 m2 venous thrombosis at the cannulation site was most common, with the use of a 12 fr percutaneous venous cannula.Anticoagulation therapy was initiated with unfractionated heparin.Heparin infusion rate was maintained according to anti-xa activity of 0.3 to 0.5 u/ml.There were no cases of persistent thrombosis at the cannulation site.All patients were examined clinically and with vascular ultrasonography before discharge.There was no case of bleeding, nor was any surgical intervention at the peripheral cannulation site needed.Based on the available information, the thrombosis at the cannulation site malfunction may have been attributed to the medtronic products.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Literature citation: heinisch, p.P., bartkevics, m., beck, m.J., erdoes, g., glöckler, m., humpl, t., carrel, t.And kadner, a., 2021.Right axillary thoracotomy in congenital cardiac surgery: analysis of percutaneous cannulation.The annals of thoracic surgery, 112(6), pp.2047-2053.The e-published date has been used as the event date.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: BIO-MEDICUS NG 15 FR VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15904073
• MDR Text Key: 307892654
• Report Number: 2184009-2022-00394
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K180453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96670-115
• Device Catalogue Number: 96670-115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 12/02/2022
• 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 Age: 2 YR
• Patient Sex: Female
• Patient Weight: 11 KG