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

Model Number PIKV

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problem Blood Loss (2597)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

Udi# (b)(4).Additional manufacturer narrative: additional information has been requested from the healthcare provider.There has been no response at this time.There is currently insufficient information to determine the root cause of this event.The subject device is not available for evaluation.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.If new information becomes available, a supplemental report will be submitted.

Event Description

Edwards received information that during an arterial cannulation for circulatory support, the femoral vein was punctured and the cannula was inserted with no reported difficulties.It was noted that it was not possible to slide the guidewire more than 30cm.In order to remove the guidewire, the cannula and guidewire both had to be removed.The cannula that was used was not an edwards cannula.There was 500cc blood loss as a result of this procedural complication.No other details were provided.

Event Description

No specific re-intervention was performed on the patient.The blood loss was managed through standard practice.The patient was noted as to be discharged.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Per the instructions for use (ifu), "proper surgical procedures and techniques are the responsibility of the medical profession.Described procedures are provided for informational purposes only.Each physician must determine the appropriate use of this device for each patient based on medical training, experience, the type of procedure employed, and the benefits and risks associated with device use." the ifu was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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 corrective or preventative actions are required.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.If new information becomes available, a supplemental report will be submitted.

Manufacturer Narrative

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

• Brand Name: FEMORAL ACCESS VENOUS CANNULAE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7627202
• MDR Text Key: 111976909
• Report Number: 3008500478-2018-00072
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K123303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2020
• Device Model Number: PIKV
• Device Catalogue Number: PIKV
• Device Lot Number: 60989515
• 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
• Patient Outcome(s): Hospitalization; Other