MAUDE Adverse Event Report: CARDIACASSIST, INC. PROTEK DUO VENO-VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 5140-4629

Device Problem Migration (4003)

Patient Problems Cardiac Perforation (2513); Blood Loss (2597)

Event Date 11/13/2019

Event Type  Injury  

Event Description

It was reported that a protek duo cannula was implanted into the patient and position of the cannula was confirmed using fluoroscopy and transesophageal echocardiography (tee).Following implant and verification of placement, the patient was moved from the or table to the icu bed.It was reported that the patient lost the ability to flow on circuit and a large amount of blood was noted from the patient's chest tubes.The patient's chest was re-opened and the cannula tip was visualized protruding through the right ventricular outflow tract (rvot).The surgeon was able to control the patient's bleeding, re-positioned the cannula, and repaired the rvot.The patient remained on support following the event and it was reported that the patient was critically ill with poor prognosis.The physician assessed the cause to be related to the moving of the patient.No further relevant information has been received to date.The suspect cannula has not been received by the manufacturer for product analysis to date.The lot number of the suspect cannula is unknown to date.Device history records were reviewed for the cannulas shipped to the facility that had not expired by the date of the event.The device history records did not identify any deviations or non-conformities.

• Brand Name: PROTEK DUO VENO-VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIACASSIST, INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer (Section G): CARDIACASSIST, INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: njemile crawley ; 620 alpha drive; pittsburgh, PA 15238 ; 2812287200
• MDR Report Key: 9439111
• MDR Text Key: 170908517
• Report Number: 2531527-2019-00054
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/09/2019

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: 5140-4629
• Device Catalogue Number: 5140-4629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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