MAUDE Adverse Event Report: MC3, INCORPORATED MC3 SOFT-FLOW AORTIC CANNULA; AORTIC CANNULA FOR CARDIOPULMONARY BYPASS

Model Number 5768

Device Problem Device Operational Issue (2914)

Patient Problems Stroke/CVA (1770); Tissue Damage (2104)

Event Date 09/19/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturer has evaluated a device from the same lot.No failure was detected.Manufacturer received complaint device on november 1, 2017; evaluation of complaint device is not yet complete.

Event Description

Distributor received information that during a case, as the customer was manipulating this cannula, the body of the cannula disconnected from the connector.The product was replaced with another to complete the case.The patient was reported to have suffered a stroke.The physician stated this patient was very sick and there were multiple factors that could have caused the stroke, however it was possible that the cannula caused or contributed to the adverse outcome.Upon further questioning by sales person, it was reported that there was no note of stroke in patient records.Hospital personnel reported "some injury" due to "needed additional suturing r/t the larger opening created by insertion of another cannula." the hospital has not released the product for return to manufacturer at this time.User facility report (mw5072511) states: "aortic cannula used by cardiothoracic surgeon during open heart surgery for multi-vessel cad leaked air at the connector.This is the second occurrence we've had with this product; unfortunately the surgery team threw away the box and we were unable to retrieve, so do not have a lot number or expiration date.The catalog numbers are the same, 5768." complaint device returned on november 1, 2017.Evaluation of device is in progress.

• Brand Name: MC3 SOFT-FLOW AORTIC CANNULA
• Type of Device: AORTIC CANNULA FOR CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MC3, INCORPORATED; 2555 bishop circle west; dexter MI 48130
• Manufacturer (Section G): MC3, INCORPORATED; 2555 bishop circle west; dexter MI 48130
• Manufacturer Contact: adam viitala ; 2555 bishop circle west; dexter, MI 48130 ; 7349959089
• MDR Report Key: 7109108
• MDR Text Key: 94635020
• Report Number: 3011468686-2017-00002
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2017

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?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2019
• Device Model Number: 5768
• Device Catalogue Number: 5768
• Device Lot Number: 1607101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 12/12/2017
• 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