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

Model Number 77420

Device Problem Device Slipped (1584)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/17/2011

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.The return of the product, facility, initial reporter, patient impact and demographics were requested but could not be provided by (b)(6).Should the product be returned, additional information received, or if the completed investigation yields new information, a follow up report will be submitted.No unique device identifiers (model or lot numbers) were provided.The model and catalog numbers were chosen arbitrarily based on the product description in the report.The 510k number was chosen based on this selected model number.

Event Description

Medtronic received information notification from the therapeutic goods administration a device incident report was received indicating that during a case, the suture collar from this arterial cannula fell off the cannula into the patient's aorta.The operation was completed.The patient was taken to radiology, using x-ray the suture collar was located in the femoral artery.A second surgery was performed the same day and the suture collar was retrieved.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

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): MEDTRONIC PERFUSION SYSTEMS; 7611 northland drive; brooklyn park MN 55428
• Manufacturer (Section G): MEDTRONIC PERFUSION SYSTEMS; 7611 northland drive; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6195568
• MDR Text Key: 63055179
• Report Number: 2184009-2016-00048
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K031037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2016

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 Model Number: 77420
• Device Catalogue Number: 77420
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided; 04/04/2017
• Supplement Dates FDA Received: 04/11/2017; 09/28/2017
• Was Device Evaluated by Manufacturer?: No
• 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