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

Model Number 77524

Device Problem Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

Medtronic received information indicating that while demonstrating the eopa cannula assembly, the introducer could be inserted beyond its stopping point, causing the tip to extend too far out of the tip of the cannula.There was no patient involvement in this event.

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, visual inspection showed no outward signs of damage.Performance analysis showed that the dilator was inserted into the hemostasis cap all the way to the hub and the dilator tip was located as expected.After the dilator hub was inserted into the hemostasis cap with minimal force and the dilator tip appeared to protrude too far from the device.The evaluation of this product event remains ongoing.If additional information is obtained a supplemental report will be submitted.There was no patient involvement for this product event.(b)(4).

Manufacturer Narrative

Additional evaluation of the returned device determined that the device met design specification.Additionally, 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.A cause of this event could not be determined.

• 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: 4187163
• MDR Text Key: 5094324
• Report Number: 2184009-2014-00082
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2014

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: 02/28/2017
• Device Model Number: 77524
• Device Catalogue Number: 77524
• Device Lot Number: 2014021683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 10/20/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2014
• 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