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

Model Number 5140-4629

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Type  Injury  

Event Description

A physician reported to a tandemlife employee that a different physician at another facility had experienced a right ventricle perforation issue with a tandemlife product.There was no further information available.Attempts were made for further information; however none has been received to date.No additional or relevant information has been received to date.

• Brand Name: PROTEK DUO VENO-VENOUS CANULA
• 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: 8923964
• MDR Text Key: 155326750
• Report Number: 2531527-2019-00048
• 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: Physician
• Type of Report: Initial
• Report Date: 08/22/2019

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: 08/01/2019
• Initial Date FDA Received: 08/22/2019
• 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): Life Threatening; Required Intervention