MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM QUATTRO CATHETER; CENTRAL VENOUS CATHETER

Model Number	8700-0660-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Cardiac Perforation (2513)
Date of Event	01/04/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The date of event is an approximated date (date when the incident was reported to the hospital) the quattro catheter used at the time of the event was not returned for evaluation and has been likely disposed.Therefore, a physical investigation will not be performed.A supplemental report will be filed if the product is returned and investigation has been completed.Based on available information, a passive leg raise test to predict fluid responsiveness was performed by nursing staff.The passive leg raising test is a bedside test to evaluate the need for further fluid resuscitation in critically ill patients.Authors of the publication suspected that this movement led to dislocation and then perforation of the right atrium.After approximately 30 minutes, the patient progressively developed severe hypotension, went into obstructive shock, and a pigtail catheter was used to drain fluids from the pericardium.Pericardial tamponade was identified and treated by pericardial puncture to clear the fluid.Transesophageal echocardiography (tee) detected a perforation of the right atrial roof laterally adjacent to the superior vena cava.Pericardial tamponade (compression of the heart caused by fluid collecting in the sac surrounding the heart) is a serious medical condition in which blood or fluids fill the space between the heart and the heart muscle.This places extreme pressure on the heart and prevents the heart's ventricles from expanding fully and keeps the heart from functioning properly.Based on available information, event of pericardial tamponade was serious because led to treatment with open surgery.Event was probably related to quattro catheter due to relevant timing and location of perforation of the right atrium, which in turn led to pericardial tamponade.Event was not unanticipated because perforation of the right atrium by quattro catheter is listed as possible complication in the instructions for use.In agreement with the authors, perforation of the right atrium by quattro catheter was probably caused by the passive leg raising test; this should be avoided in patients with inserted in vasculature catheter.
Event or Problem Description
An article from an incident received by (b)(6) hospital (b)(6), department of internal medicine and published online stated the following: a patient was hospitalized due to cardiopulmonary arrest.During hospitalization, coronary angiography was performed including percutaneous coronary intervention of the left anterior descending artery.A quattro catheter was inserted on the patient femoral vein for ivtm treatment.After approximately 30 minutes, the patient progressively developed severe hypotension.Pericardial tamponade was identified and treated by pericardial puncture to clear the fluid.Transesophageal echocardiography (tee) detected a perforation of the right atrial roof by the quattro catheter.Open surgery was immediately performed to remove the catheter.The patient was discharged from the hospital without any further complication 10 days later.

• Brand Name: ZOLL IVTM QUATTRO CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7251650
• Report Number: 3010617000-2018-00144
• Device Sequence Number: 100354
• Product Code: NCX
• UDI-Device Identifier: 00849111075121
• UDI-Public: 00849111075121
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2018

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
• Operator of Device: Health Professional
• Device Model Number: 8700-0660-40
• Device Catalogue Number: 8700-0660-40
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR