MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number PR9

Device Problem Use of Device Problem (1670)

Patient Problem Blood Loss (2597)

Event Date 09/03/2014

Event Type  Injury  

Event Description

Edwards received information that bleeding and hemodynamic instability requiring treatment occurred during use of a pr9 catheter.Through investigation, it was learned after the cardiac surgical procedure was completed and the patient was weaned from cardiopulmonary bypass (cpb), protamine was administered.The pr9 was not discontinued when protamine was administered.Having thought the pr9 had already been removed from the patient, the perfusionist started to disassemble the cpb circuit.With the pr9 still in position in the coronary sinus, detachment of the cpb circuit allowed bleeding from the pr9 cardioplegia port (green port).The patient experienced hypotension and bradycardia due to blood loss.While troubleshooting the hypotension and bradycardia, it was identified that the pr9 was still in position, connected to the bypass circuit with the stopcock ¿on¿ and blood was leaking through the tubing into the bypass reservoir.The green stopcock was turn ¿off¿ and the pr9 was removed from the patient.The patient was given epinephrine and albumin followed by fluid resuscitation and 2 units of packed red blood cells.It was reported the patient experienced some vision loss.

Manufacturer Narrative

Device not returned for evaluation.Based on the information reported the root cause of the patient's blood loss was not removing the device per our instructions for use.Our ifu provides the following directions in regards to withdrawing the device."1.Proplege device removal should occur prior to or coincident with the reversal of anticoagulation." in this case, the device remained in the patient after administration of protamine and continued to remain in place after the detachment from the cpb circuit.There was no allegation of a malfunction of the device related to this issue.A review of the ifu was conducted and no inadequacies have been identified with regards to warning, contraindications, and the directions/conditions for the successful use of the device.

• Brand Name: PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT 84020
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 12050 lone peak parkway; draper UT 84020
• Manufacturer Contact: walt wiegand ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 4237883
• MDR Text Key: 5064860
• Report Number: 3008500478-2014-00135
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2014

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: PR9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2014
• Initial Date FDA Received: 11/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 81