MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS BIOMEDICUS MULTISTAGE FEMORAL VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 96880-025

Device Problem Kinked (1339)

Patient Problems Pleural Effusion (2010); Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 01/19/2013

Event Type  Injury  

Manufacturer Narrative

Citation: passage, jurgen article title: right ventricular perforation during femoral venouscannulation ¿ lessons learned heart, lung and circulation 2013 sep;22(9):772-4.No unique device identifier (lot number) was provided.Without this information, it could not be determined whether these observations have been previously reported.Conclusion: medtronic cannot confirm or deny the relationship between a product issue and the reported patient affects as no product has been returned to date.Medtronic will continue to monitor for future occurrences and trends.

Event Description

Medtronic received information via literature regarding the potential complications from using femoral venous cannulae during cardiopulmonary bypass.The data was collected from one procedure at (b)(6) hospital.The study included one, (b)(6) year old female patient that underwent mitral valve surgery.During the procedure after inserting a medtronic femoral venous cannula, the customer could not locate the tip of the cannula in the superior vena cava (svc) as expected.The customer used transoesophagel echo (toe) in an attempt to locate the cannula and discovered a small pericardial effusion, causing cardiac tamponade with a collapse of blood pressure and cardiac output.The customer rapidly cannulated the femoral artery and achieved satisfactory haemodynamics.A sternotomy was then performed, with subsequent discovery that the venous cannula had perforated the apex of the right ventricle.The customer suspected the perforation was a result of a kink in the tip of the cannula and the cause of the pericardial effusion drainage, without any air entrainment.The venous cannula was repositioned, perforation repaired and successful completion of the mitral valve replacement procedure.There were no additional adverse patient effects, and the patient was discharged.The product is not expected to return to medtronic.

Manufacturer Narrative

Conclusion: medtronic cannot confirm or deny the complaint of a kink at the tip of the cannula as no product has been returned to date.A root cause of this occurrence cannot be determined without returned product.The device history record could not be reviewed, as no lot number was provided.A review of past complaints received for this model number showed no trends warranting escalation related to this occurrence.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.

Manufacturer Narrative

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

• Brand Name: BIOMEDICUS MULTISTAGE FEMORAL VENOUS 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: 6195889
• MDR Text Key: 63059549
• Report Number: 2184009-2016-00049
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K052524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/21/2016

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: 96880-025
• Device Catalogue Number: 96880-025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided; 12/21/2016; 12/21/2016
• Supplement Dates FDA Received: 01/13/2017; 09/27/2017; 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
• Patient Age: 70 YR
• Patient Weight: 58