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

Model Number 77420

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2014

Event Type  malfunction  

Event Description

Medtronic received information that at the end of a case two cuts were noticed in the outer lumen of this eopa arterial cannula.There was no leak as the inner lumen remained intact.Since the procedure had already been successfully completed the cannula was not replaced.There was no adverse effect on the patient.The product was returned for analysis.

Manufacturer Narrative

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 eopa arterial cannulae.At this time, there have not been any reports of damage to the inner lumen of any of the cannulae, any leaks, or any adverse patient effects as a result of these issues.(b)(4).

Event Description

Medtronic received information that at the end of a case two cuts were noticed in the outer lumen of this eopa arterial cannula.There was no leak as the inner lumen remained intact.Since the procedure had already been successfully completed the cannula was not replaced.There was no adverse effect on the patient.The product was returned for analysis.

Manufacturer Narrative

Upon receipt at medtronic's quality laboratory, visual inspection confirmed that the cannula body had split in two different locations in the narrower section of the cannula.The splits were in the outer lumen of the device, exposing the wire winding, but did not continue through the inner lumen.The product was sent to the contract manufacturer for this cannula for additional examination and determination of root cause.(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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 3760377
• MDR Text Key: 4686044
• Report Number: 2184009-2014-00022
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031037
• 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,Followup
• Report Date: 05/06/2014

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: 05/31/2016
• Device Model Number: 77420
• Device Catalogue Number: 77420
• Device Lot Number: 2013051042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2014
• Initial Date FDA Received: 04/20/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2013
• 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