MAUDE Adverse Event Report: EDWARDS LIFESCIENCES QUICKDRAW VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number QD22

Device Problems Mechanical Problem (1384); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2018

Event Type  Injury  

Manufacturer Narrative

The subject device is not available for evaluation, as it was discarded by the hospital staff.The clinical observation was unable to be confirmed.The device history record (dhr) was not reviewed as the lot number was not provided.Also, the reported event does not allege a malfunction that could be related to a manufacturing deficiency and/or one was not confirmed through investigation.Based on the information received, use error most likely contributed to the event.There was no indication or allegation of a device malfunction contributing to the event.The instructions for use (ifu) has been reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Edwards will continue to review and monitor all events through the use of edwards quality systems.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No further corrective or preventative actions are required at this time.

Event Description

Edwards received information that failure of blood removal occurred temporarily during use of the 22 fr venous cannula which was connected to cardiopulmonary bypass machine.This occurred because the customer pulled or moved the cannula too much from the smaller patient body and the fifth side hole exposed in the air which led the cannula to suck air.There was no exchange of cannula.There was no delay in the procedure.There were no patient complications reported.The customer is a frequent user of the 25 fr cannula not of the 22 fr device.

Manufacturer Narrative

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

• Brand Name: QUICKDRAW VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 7682419
• MDR Text Key: 113800557
• Report Number: 3008500478-2018-00074
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

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: QD22
• Device Catalogue Number: QD22
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 07/12/2018
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other