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 Great Vessel Perforation (2152)

Event Date 09/01/2014

Event Type  Injury  

Manufacturer Narrative

The device was discarded by the customer and was not returned for analysis.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified in the device history record that would have contributed to this product event.

Event Description

Medtronic received information indicating that during a procedure the introducer of this eopa cannula extended too far from the tip and punctured the posterior wall of the patient's aorta.The surgeon repaired the aorta without further adverse patient effect.The device will not be returned as it was discarded by the customer.

Manufacturer Narrative

The product was discarded by the customer.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Should the product be returned or additional information obtained, a follow-up report will be submitted.Medtronic was unable to obtain patient information from the customer.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 4187162
• MDR Text Key: 12668773
• Report Number: 2184009-2014-00081
• 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,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2014

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: 02/28/2017
• Device Model Number: 77524
• Device Catalogue Number: 77524
• Device Lot Number: 2014021683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2014
• Initial Date FDA Received: 10/20/2014
• Supplement Dates Manufacturer Received: Not provided; 11/14/2014
• Supplement Dates FDA Received: 12/10/2014; 09/15/2017
• 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
• Patient Outcome(s): Required Intervention