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

Model Number 77424

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2014

Event Type  malfunction  

Event Description

Medtronic received information indicating that while inserting this eopa arterial cannula, the outer layer of the cannula split, exposing the wire winding.The cannula was removed and replaced with a new device.There were no adverse patient effects as a result of the split.The cannula was returned to medtronic for analysis.

Manufacturer Narrative

Upon receipt at medtronic's quality laboratory, visual inspection confirmed that the cannula body had split in the narrower section of the cannula.The split was in the outer lumen of the device, exposing the wire winding, but did not continue through the inner lumen.Medtronic and the contract manufacturer for this device have initiated an investigation into the root cause of this issue.(b)(4).

• 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
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: mike gaffney ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635265629
• MDR Report Key: 3803689
• MDR Text Key: 4476876
• Report Number: 2184009-2014-00032
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K031037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: 77424
• Device Catalogue Number: 77424
• Device Lot Number: 2013041644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2014
• Initial Date FDA Received: 05/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2013
• 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