MAUDE Adverse Event Report: PERFUSION SYSTEMS ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number 72224

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/26/2023

Event Type  Injury  

Event Description

Medtronic received information via literature regarding samurai cannulation, a modified version of the direct true lumen cannulation that has been used in surgery for acute type a aortic dissection.All data was collected from a single center between october 2013 to november 2022.The study population included 146 patients, medtronic 24 fr select series straight tip arterial cannula was used during the samurai cannulation (lot numbers not provided).The cannula was fixed to the sternal wound retractor.Among all patients, no deaths occurred.Among all patients, adverse events included an initial cerebral malperfusion after cannulation in one patient; the forehead oxygen saturation value fluctuated after cardiopulmonary bypass (cpb) installation.Transesophageal echocardiography revealed a false lumen dominant perfusion through a large tear in the aortic arch.After the perfusion cannula was turned around so that the bevel of the tip faced opposite to the tear, the forehead oxygen saturation recovered and the transesophageal echocardiography findings improved.Five cases of preoperative malperfusion of the lower body.Samurai cannulation-related complication occurred in one patient with periaortic adhesions; an adventitial injury while placing umbilical tapes around the aorta resulted in bleeding, which was controlled with manual compression.Femoral cannulation was instead used in this case.The patient underwent aortic repair and went home without major complications.Unexpected major bleeding from the untouched aortic root before establishment of cardiopulmonary bypass (cpb) occurred in 2 cases.Based on the available information, the initial cerebral malperfusion, preoperative malperfusion of the lower body and samurai cannulation-related complication may have been attributed to medtronic product.Among all patients, no device malfunctions occurred.Medtronic received additional information from the author that of the adverse events that were mentioned within the article, none of them were related directly to medtronic devices.

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.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.

Manufacturer Narrative

Correction b5.Among all patients, 18 deaths occurred.Based on the available information, none of the deaths were attributed to the medtronic product.Strokes occurred in eight patients.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ARTERIAL 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: 18756961
• MDR Text Key: 335987207
• Report Number: 2184009-2024-00094
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K840002
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72224
• Device Catalogue Number: 72224
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2024
• 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): Required Intervention