MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS DLP AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 10012

Device Problems Difficult to Remove (1528); Sticking (1597); Positioning Problem (3009)

Patient Problems Death (1802); Aortic Dissection (2491)

Event Date 11/23/2015

Event Type  Injury  

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual analysis confirmed the inability to remove the introducer needle from the cannula.Conclusion: investigation at medtronic and its supplier identified that the anomaly is a result of variation within the manufacturing process.Corrective and preventative actions are in progress.(b)(4).

Event Description

Medtronic received information indicating that after cannulation, the customer reported the luer lock was difficult to turn and the needle could not be removed from the catheter of this cannula.The customer reported that the blue gasket seemed to be stuck to the catheter and the luer lock was also stuck.The product was removed and replaced with another that functioned as expected.Upon coming off bypass, the patient's pressures were depressed and a dissection in the ascending aorta was found.The patient was put back on pump to repair the vessel.The customer reported later that day the patient passed away due to multiple organ failure, indicating the cause of death was not related to the medtronic product malfunction.

• Brand Name: DLP AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland drive; brooklyn park MN 55428
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5324903
• MDR Text Key: 34322342
• Report Number: 2184009-2015-00122
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790565
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/25/2015

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 Expiration Date: 10/31/2018
• Device Model Number: 10012
• Device Catalogue Number: 10012
• Device Lot Number: 2015101138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2015
• 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