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

Model Number 5140-5131

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

Patient Problem Arrhythmia (1721)

Event Date 08/29/2019

Event Type  Injury  

Event Description

It was reported that a patient had cardiac arrhythmias during tandemheart insertion, related to the tandemheart device.This resolved on (b)(6) 2019.The day prior, the patient had pre-existing atrial and ventricular arrhythmias.The patient had documented prolonged qt prior to the tandemheart insertion, with ventricular tachycardia, ventricular fibrillation, and torsades documented.The patient also had a left ventricle atrial cannula, that was not a tandemlife product.To treat, the patient was given lidocaine, amiodarone, procainamide and several defibrillations.Prior to the placement of a ventricular assist device, the electrophysiologist felt that the ventricular tachycardia was coming from the right ventricle.The device serial numbers are unknown and the device has not been received to date.No additional, relevant information has been received to date.

• Brand Name: PROTEK DUO VENO-VENOUS CANULA
• Type of Device: CATHETER, CANNLA 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: 9251885
• MDR Text Key: 164254440
• Report Number: 2531527-2019-00051
• 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: 10/29/2019

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: 5140-5131
• Device Catalogue Number: 5140-5131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 10/29/2019
• 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): Other
• Patient Age: 44 YR