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 Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturer has evaluated a device from the same lot.No failure was detected.Manufacturer received complaint device on (b)(6) 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.No adverse patient effects were reported.The device was not released by user facility for return to manufacturer.User facility report (mw5072512) states: "noticed there was an issue with the cannula-connector bond.Due to this issue, surgeon placed a new aortic cannula.At the end of the procedure, the surgeon removed the aortic cannula.Replacing the initial aortic cannula caused the insertion hole to be larger and surgeon was unable to repair with initial safety sutures.Had to use add'l suture with pledgets placed to stop aortic bleeding." complaint device returned on (b)(6) 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
• MDR Report Key: 7109118
• MDR Text Key: 95767413
• Report Number: 3011468686-2017-00003
• 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?: No
• Is this a Product Problem Report?: Yes
• 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