MAUDE Adverse Event Report: MC3 INC SOFT-FLOW EXTENDED AORTIC CANNULA

Model Number 4949

Device Problem Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

The device was returned and examined by manufacturer.It was determined to meet specification.If more information is received by manufacturer the mdr will be updated.Ifu warnings include the following: positionable suture ring must remain exterior to the heart and all vessels.Do not insert the suture ring into the heart or any vessel.

Event Description

Information received by manufacturer (mc3) from distributor ((b)(4)) on march 29, 2017.Upon arterial cannulation for a mitral valve repair, surgeon inserted soft flow cannula tip into aorta and inadvertently placed the portion of the cannula with the suture ring into the aorta.It was reported that the surgical procedure was modified to safety remove the cannula with the suture ring attached from the aorta.When it was time to remove the cannula from the patient at the end of the case, the surgeon was concerned that the suture ring could fall off the cannula body.As a result, he decided to put the patient on circulatory arrest in order to ensure safe removal of the device without detachment of the suture ring.It was confirmed that the device was safely removed and the suture ring remained attached to the device.There was no reported adverse effect to the patient.

• Brand Name: SOFT-FLOW EXTENDED AORTIC CANNULA
• Type of Device: AORTIC CANNULA
• Manufacturer (Section D): MC3 INC; 2555 bishop circle west; dexter MI 48130
• Manufacturer (Section G): MC3 INC; 2555 bishop circle west; dexter MI 48130
• Manufacturer Contact: martha rumford ; 2555 bishop circle west; dexter, MI 48130 ; 7349959089
• MDR Report Key: 6749819
• MDR Text Key: 81491262
• Report Number: 3011468686-2017-00001
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 10854916006048
• UDI-Public: 10854916006048
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132811
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/28/2017

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 Model Number: 4949
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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