MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS BIO-MEDICUS NG 19 FR ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 96570-119

Device Problems Difficult To Position (1467); Device Dislodged or Dislocated (2923); Improper Flow or Infusion (2954)

Patient Problems Death (1802); Cardiac Perforation (2513)

Event Date 05/12/2016

Event Type  Death  

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.

Event Description

Medtronic received information indicating that during a pediatric procedure in the catheterization laboratory, the patient started to decompensate.The patient was cannulated in the neck with a 96570-119 cannula for venous return and put on support.The patient coded and chest compressions were started.The venous return cannula was pulled out of position while attempting to connect it to the circuit.Several attempts were made to re-cannulate with the same cannula, as compressions continued.After flow issues were observed with the first cannula, a second cannula was placed.Flow issues remained.The surgeon attempted to flush out the cannula, but they were unable to obtain flow.The patient passed away.The technique used for cannula insertion did not include the use of a guidewire which lead to blood loss through the guidewire lumen of the over-the-wire obturator.The preliminary autopsy indicated the heart had been perforated during the cannula insertion.The cannula was discarded by the customer and will not be returned to medtronic for analysis.

Manufacturer Narrative

Corrected information: sex.

• Brand Name: BIO-MEDICUS NG 19 FR ARTERIAL CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): MEDTRONIC PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5706568
• MDR Text Key: 46811245
• Report Number: 2184009-2016-00013
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 96570-119
• Device Catalogue Number: 96570-119
• Device Lot Number: 209987335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2015
• 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): Death
• Patient Age: 4 YR
• Patient Weight: 22