MAUDE Adverse Event Report: MC3 INC. MC3; CARDIOVASCULAR CANNULA

Model Number	7071
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the end of a cardiopulmonary bypass surgery, a new cannula was being prepared for an ecmo procedure.Ecmo is long-term use and it is off-label use for this device.It was noticed by the customer that the connector had become separated at the glue joint of the cannula during the set up for the ecmo procedure.The cannula was subsequently utilized for the ecmo procedure with a different tubing connector.It is not possible to analyze the actual device involved in this report because it was not returned to mc3 for evaluation.Mc3 has manufacturing controls of this bond joint and all information reviewed and testing results confirm that specifications are met.An in depth review of production data, trend data, records and testing did not uncover any root cause of bond strength variation that could have caused the malfunction.With excessive force, it is possible to break the glue joint bond prior to disconnection of the tubing to barb connection.A force may have been applied to the bond joint greater than the 20 pound specification limit.The root cause of the problem experienced remains inconclusive.
Event or Problem Description
The customer reported a malfunction to the distributor on 12/27/2019.The distributor forwarded information about this malfunction on 12/31/2019 to mc3 inc.The customer described the following: during the preparation for an ecmo case using the mc3 soft flow angled tip arterial cannula, when the cannula was clamped between wire winding and connector, the device separated at the connection of the cannula body and the connector.After the separation occurred, the cannula was left in place with a different connector used to connect the cannula to the perfusion circuit.The patient is on ecmo waiting for a transplant.There is no allegation that this separation caused any issues for the patient.The device was used at the start of the ecmo case.There were no adverse patient effects.The patient was re-cannulated so the original cannula is no longer in the ecmo circuit.The hospital did not release the cannula.The malfunction occurred post cpb procedure and during the set up for the ecmo procedure.

• Brand Name: MC3
• Common Device Name: CARDIOVASCULAR CANNULA
• Manufacturer (Section D): MC3 INC.; 2555 bishop circle west; dexter MI 48130
• MDR Report Key: 9643843
• Report Number: 3011468686-2019-00004
• Device Sequence Number: 11308892
• Product Code: DWF
• UDI-Device Identifier: 10854916006727
• UDI-Public: 10854916006727
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 7071
• Device Catalogue Number: 7071
• Device Lot Number: 1802100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1