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

Model Number QD25

Device Problems Product Quality Problem (1506); Material Separation (1562)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2019

Event Type  malfunction  

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.The instructions for use (ifu) warns, ¿visually examine the quickdraw venous cannula, introducer(s), and components.Do not use if device shows signs of damage (i.E., cuts, kinks, crushed areas), or if package is damaged or open.¿ the subject was not returned for evaluation; therefore, the reported event cannot be confirmed.The root cause of this event cannot be determined at this time.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported that the perfusionist opened a new quickdraw venous cannula from the shelf and was able to manually separate the cannula from the connector.They were surprised that they were able to loosen the connector connection without what they felt was much manipulation.This device was not used.

Manufacturer Narrative

D4: udi #(b)(4) h3: evaluation summary: customer report of separated connector from qd cannula was confirmed.As received, the connector end of the cannula was easily separated from main cannula body.No indications of bonding material were found on both the detached connector end and the cannula body end.Cannula was observed to have multiple kinks along the cannula body.No other visual damage, contamination, or other abnormalities were found to the device.H10: additional manufacturer narrative: updated sections d4 (expiration date, udi #), h4.Field corrective action (fca-152) has been initiated for the quickdraw venous cannula separation issue.Review of the device history record (dhr) showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Subsequent investigation and engineering evaluation confirmed a manufacturing defect.Investigation of the root cause is currently under way.H11: corrected data: updated section h7.

Manufacturer Narrative

Reference capa-20-0014.

• Brand Name: QUICKDRAW VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9369746
• MDR Text Key: 204991785
• Report Number: 3008500478-2019-00171
• 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: distributor,health profession
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2019
• Device Model Number: QD25
• Device Catalogue Number: QD25
• Device Lot Number: 62067518
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1