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

Model Number	4949
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: AORTIC CANNULA
• Manufacturer (Section D): MC3 INC; 2555 bishop circle west; dexter MI 48130
• MDR Report Key: 6749819
• Report Number: 3011468686-2017-00001
• Device Sequence Number: 13805824
• Product Code: DWF
• UDI-Device Identifier: 10854916006048
• UDI-Public: 10854916006048
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K132811
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2017
• Initial Report FDA Received Date: 07/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention