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

Model Number 7071

Device Problem Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2017

Event Type  malfunction  

Event Description

Distributor received information that prior to use, the customer was manipulating this cannula and the cannula body became disconnected from the connector.The product was not used and had no patient involvement.User facility filed voluntary report (b)(4), reporting a connector issue; "the cannula was not preserved." manufacturer is unable to evaluate device issue due to the disposal of the complaint device.

• 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: 7109140
• MDR Text Key: 95171551
• Report Number: 3011468686-2017-00004
• 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 Model Number: 7071
• Device Catalogue Number: 7071
• Device Lot Number: UNKNOWN
• 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?: Device Not Returned to Manufacturer
• 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