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

Model Number QD25

Device Problem Difficult to Insert (1316)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Multiple Organ Failure (3261)

Event Date 05/21/2020

Event Type  Death  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was discarded.If additional information is received a supplemental mdr will be submitted.There are many causes of perioperative bleeding in these patients, they are anticoagulated during the procedure, they are hypothermic, and their blood components are damaged by the cpb machine.Some of the bleeding may be associated with an intravascular device; this can typically be controlled with gentle pressure to the site.The cause of the event cannot be determined.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

Edwards received information that intraperitoneal bleeding was detected during use of this 25 cannula.This device was inserted from left femoral vein.The guidewire could be inserted into the patient¿s atrium without resistance.The cannula was supposed to be inserted at the position of approximately 45cm, however, resistance was felt at a position of approximately 30cm from the insertion.The surgeon pulled back the cannula to the position of approximately 5cm from the insertion.The guidewire was re-inserted, and it could be inserted into the patient¿s atrium without resistance.The cannula could be inserted without resistance, and it was fixed at the position of 47cm.After starting cpb, abdominal protuberance was confirmed, and pooling of blood was observed into the abdominal cavity.The operative procedure was changed to hemostasis, and aortic cross clamping was released.Incision was expanded to hypogastrium for detailed check, however bleeding point was unable to be identified, so the cannula was removed.After removing the cannula, bleeding was confirmed near location where the right testicular vein flow into the inferior vena cava, and it was treated.The device was not returned for evaluation as it was discarded at the hospital.On postoperative day twenty-seven (27), the patient expired due to multi organ failure.

Manufacturer Narrative

D4: udi #: (b)(4).H10: additional manufacturer narrative: updated sections d4 (udi #, expiration date), h4.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.H11: corrected data: corrected section h6 (results & conclusions codes).

Event Description

Additional information received: there was no device malfunction, and there was no causal relation between the device and the patient death.

• 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: 10876168
• MDR Text Key: 217372158
• Report Number: 3008500478-2020-00212
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K200499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2021

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: 04/15/2021
• Device Model Number: QD25
• Device Catalogue Number: QD25
• Device Lot Number: 62067519
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 12/16/2020; 05/17/2021
• Supplement Dates FDA Received: 12/21/2020; 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Other
• Patient Age: 70 YR
• Patient Weight: 70