MAUDE Adverse Event Report: PERFUSION SYSTEMS BIOMEDICUS MULTISTAGE FEMORAL VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number 96880-025

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

Patient Problems Thrombocytopenia (4431); Unspecified Tissue Injury (4559)

Event Date 04/04/2023

Event Type  Injury  

Manufacturer Narrative

B3: the published date has been used as the event date.Literature citation authors: luis fernando gonzalez-ciccarelli, raquel bartz and dirk varelmann journal name: intensive care medicine year: 2023 issue #: 49 title of article: post-ecmo decannulation right atrial fibrin sheath literature reference: 10.1007/s00134-023-07052-5 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

Event Description

Medtronic received information from a literature article regarding an extra corporeal membrane oxygenation (ecmo) procedure for a patient that required veno-arterial ecmo via a right femoral 25 fr bio-medicus multi-stage percutaneous drainage cannula and blood return to a right axillary 8 mm side graft for biventricular dysfunction following a ventricular septal defect closure, aortic root repair, and aortic valve replacement.Postoperatively, the patient developed an elevated pf4 antibody, elevated serotonin release assay, and thrombocytopenia consistent with heparin-induced thrombocytopenia.On postoperative day 6 the patient was successfully decannulated from ecmo.The customer stated that given atrial fibrillation and the need for possible cardioversion on postoperative day 10, a transesophageal echocardiogram was performed.A tubular fibrin sheath was observed in the patient¿s right atrium (ra) extending to the superior vena cava to ra junction.The customer stated that this was found due to the presence of the patient¿s ecmo drainage cannula.The customer stated that ecmo cannulas can produce fibrin sheaths which may adhere to the vasculature after decannulation.The customer stated that these sheaths may ultimately embolize to the lungs if present in the venous system or provide a nidus for bacterial infection.

• Brand Name: BIOMEDICUS MULTISTAGE FEMORAL 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: 18729895
• MDR Text Key: 335714922
• Report Number: 2184009-2024-00085
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 96880-025
• Device Catalogue Number: 96880-025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• 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): Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male