MAUDE Adverse Event Report: PERFUSION SYSTEMS EOPA 3D VENTED ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 78220

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2013

Event Type  malfunction  

Event Description

Medtronic received information that after use of this cannula in a cardiopulmonary bypass (cpb) procedure, the surgeon noted that the wire in the cannula body was exposed in the area where the silk suture tie was wrapped around the cannula to secure the cannula.The cannula did not leak, and was used for the entire procedure.The exposed wire was noticed after the patient was weaned off of cpb.The surgeon elected to replace the cannula in case the patient had to go back on cpb.There was no impact to the patient.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual inspection confirmed that the cannula body had split.The device was observed under magnification and revealed an exposed wire.There was no outward damage or dimensional issue found to indicate a manufacturing defect was present.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Medtronic has initiated a formal investigation into recent events involving damage to the outer lumen of cannulae.(b)(4).

• Brand Name: EOPA 3D VENTED 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 3843517
• MDR Text Key: 4615711
• Report Number: 2184009-2014-00039
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/02/2014

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: Other
• Device Expiration Date: 06/30/2016
• Device Model Number: 78220
• Device Catalogue Number: 78220
• Device Lot Number: 2013060361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2014
• Initial Date FDA Received: 06/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1