MAUDE Adverse Event Report: PERFUSION SYSTEMS EOPA ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 77622

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

Patient Problem Aortic Dissection (2491)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information the customer reported that the patient experienced an aortic dissection, identified in theatre post bypass following use of the eopa arterial cannula.The registrar inserted the eopa dilator tip introducer without the use of a guidewire under supervision of the supervising consultant surgeon.The cannula did not exhibit the retrograde flow (bleed back) that would indicate it was correctly positioned, so registrar instructed to re-position.Good pressure swing was then observed and bleed back was normal.Proceeded to bypass.No issues seen at the cannula site.Before coming off bypass, they performed a routine lactate test.Found it was high.Post bypass, they investigated this result with the toe and found an aortic dissection.Patient being monitored and may need an endoluminal repair.

Manufacturer Narrative

H.3: device was discarded by the customer, so not available for assessment.Medtronic conclusion: a root cause of this occurrence could not be determined without a returned product.The device history record could not be reviewed as no lot number was provided.The complaint does not indicate any issues with the medtronic cannula.Per the instructions for use, this model cannula must be used with a guidewire for proper placement to avoid trauma to the back wall of the aorta.The complaint indicated that a guidewire was not used for placement, therefore this cannula was used off-label.A review of complaints received for this model number found no similar occurrences.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 the customer reported that the patient experienced an aortic dissection, identified in theatre post bypass following use of the eopa arterial cannula.The registrar inserted the eopa dilator tip introducer without the use of a guidewire under supervision of the supervising consultant surgeon.The cannula did not exhibit the retrograde flow (bleed back) that would indicate it was correctly positioned, so registrar instructed to re-position.Good pressure swing was then observed and bleed back was normal.Proceeded to bypass.No issues seen at the cannula site.Before coming off bypass, they performed a routine lactate test.Found it was high.Post bypass, they investigated this result with the toe and found an aortic dissection.Patient being monitored and may need an endoluminal repair.

• Brand Name: EOPA ARTERIAL CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 9762550
• MDR Text Key: 189464074
• Report Number: 2184009-2020-00010
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K031037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/20/2020

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: 77622
• Device Catalogue Number: 77622
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention