MAUDE Adverse Event Report: EDWARDS LIFESCIENCES QUICKDRAW VENOUS CANNULAE

Model Number QD22

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

This cannula is used to divert large volumes of blood from the heart to the cardiopulmonary bypass machine during cardiac surgery procedures.If not detected prior to use, the bypass machine may alarm for decreased flow.A partial or complete separation will require exchange of the cannula, temporary interruption of bypass, and in a worst case scenario retrieval of the device fragment.Depending on the location of the fracture/separation, it may also result in significant blood loss and the potential for injury is not remote.In this case, the connector of a cannula almost came apart during an ecmo insertion and there was no injury to the patient.The device was not returned for evaluation at this time.Therefore, the root cause for the event remains indeterminable.The device history record (dhr) review is pending.A supplemental report will be submitted upon completion of the dhr review.A supplemental report will also be submitted if the device is returned and a product evaluation is completed.

Event Description

It was reported that the connector of a venous cannulae almost came apart during an ecmo insertion.As reported, the connector came off the end of a 22fr venous cannulae cannula.The cannula was in the patient¿s groin.The doctor had just connected it to the ecmo circuit and was attempting to push the tubing on farther when the connector came out of the cannula.Ecmo was discontinued but air had entered the circuit, so a new circuit had to be set up and used.The doctor used the cannula, (still positioned in the groin), placed another 3/8x3/8 connector in place of the one that came off the cannula and went back on ecmo.There was no injury to the patient.

• Brand Name: QUICKDRAW VENOUS CANNULAE
• Type of Device: VENOUS CANNULAE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; mle-2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 7135029
• MDR Text Key: 96033106
• Report Number: 3008500478-2017-00052
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2017

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: Health Professional
• Device Expiration Date: 06/06/2019
• Device Model Number: QD22
• Device Catalogue Number: QD22
• Device Lot Number: 60913737
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/20/2017
• Date Device Manufactured: 08/21/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 52 YR