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

Model Number 77422

Device Problems Mechanical Problem (1384); Material Separation (1562); Obstruction of Flow (2423)

Patient Problem Vascular Dissection (3160)

Event Date 03/26/2024

Event Type  Injury  

Event Description

Medtronic received information that during use of an eopa arterial cannula, it was reported that the patient suffered an aortic dissection that the customer attributed to the introducer pushing back through the red cap.The case was cancelled at the time the dissection was observed.It was unclear if the patient's anatomy contributed to this event.The customer reported that the introducer was not held firmly in the red cap of the cannula and pushed back during cannulation.The customer was dissatisfied with the cannulation, and did not observe normal backflow on the cannula when the customer tested it.The customer asked for transesophageal echocardiography (tee) confirmation of the placement and was told it looked sufficient.The customer waited and asked again for the tee, however, this time it showed an aortic type b dissection.The operation was abandoned, the patient's chest was closed and the patient was taken to the angiography suite where a stent was placed in the aorta.The customer stated that they wanted to use a different sized cannula but one was not available due to medtronic supply issues.The customer believed that this contributed to the complication as the customer was used to using the 24 fr cannula.The customer stated that the 22 fr eopa seems to have a looser introducer through the red cap than the 24 fr version.The patient¿s surgery was delayed pending the stent repair and recovery.The use of the device was unspecified.The patient suffered a type b dissection of the aorta.The aorta was repaired with an intravascular stent.Medtronic received additional information that the adverse event was device related.The customer stated that the introducer was not held firmly in the red cap.As a result, the customer suggested that the hole in the red cap was not adequate to hold the introducer in place.The white introducer was inserted through the hole and down the length of the cannula body.The adverse event was not procedure or therapy related.The customer did not report any malformation of the cap.The introducer pushed back through the cap instead of staying fixed in place during cannulation.The cap did not fall off.

Manufacturer Narrative

Note on d4: the lot number of the cannula is unknown, but was reported to be one of these 3 potential lots: 2023081593, 2023121110, or 2023120461.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: EOPA 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: 19123858
• MDR Text Key: 340347731
• Report Number: 2184009-2024-00190
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 77422
• Device Catalogue Number: 77422
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/17/2024
• 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