MAUDE Adverse Event Report: EDWARDS LIFESCIENCES QUICKDRAW; VENOUS CANNULAE

Model Number QD25

Device Problems Unraveled Material (1664); Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

These cannulae are 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.In this case the device came apart and the surgeon had to cut down into the vessel and pull it out until he reached the tip.The root cause of the event remains indeterminable.This device was not returned for evaluation at this time.If new information is received, a supplemental report will be submitted.The device history record (dhr) was not able to be reviewed as the device serial number was not provided.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported that during a case the cannula of a venous cannulae came apart and the wire and cannula were unraveled when the surgeon tried to pull out the device out of the patient.He had to cut down into the vessel and pull it out until he reached the tip.No additional details were provided.

Manufacturer Narrative

Per the engineering evaluation, a manufacturing, supplier, design, ifu, and labeling defect were not confirmed.The trend is in control and the fmea line item is appropriate.Capa/pra action are not required.The device was not returned for evaluation, nor were images provided to assess for objective evidence.Device preparation, storage conditions and condition of device prior to the start of the procedure were not reported.The root cause cannot be determined at this time.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: QUICKDRAW
• Type of Device: VENOUS CANNULAE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8057652
• MDR Text Key: 126897464
• Report Number: 3008500478-2018-00092
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K981995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2018

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 Model Number: QD25
• Device Catalogue Number: QD25
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/09/2018
• Supplement Dates Manufacturer Received: 01/08/2019; 07/23/2020
• Supplement Dates FDA Received: 01/08/2019; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention