MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG CATHETER CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 10013 AVALON ELITE

Device Problem Positioning Problem (3009)

Patient Problem Death (1802)

Event Date 11/23/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).A supplemental medwatch will be submitted if additional information becomes available.

Event Description

It was reported the perfusionist placed the 13f avalon percutaneously under fluoroscopy.Patient did of at first, but when the high ventilator settings were reduced after being placed on support, the patient status declined resulting in initiation of cpr.Cpr duration was 3 minutes.Patient passed.Post-mortem was performed which uncovered a tear in the eustachian valve.(b)(4).

Manufacturer Narrative

12/16/2016 11:04 am (gmt-5:00) added by (b)(6): the product was not available for investigation; therefore a manufacturer laboratory investigation was not possible.A dhr # of the product was not provided; therefore no manufacturer dhr review was possible.A sap trend search was performed for p/n 70106.3529, failure code d-unknown disposable error / related to the reported incident and no similar complaint was found.A trackwise trend search was performed for p/n 70106.3529, failure code d-unknown disposable error / related to the reported incident and no similar complaint was found.Due to this information no systemic issue could be determined.Yet, placement of a double lumen catheter in a small infant as it is subject of this assessment is still a high risk procedure, especially if an infant with congenital heart disease is affected.The eustachian valve (ev) is an embryological remnant of the inferior vena cava that during fetal life helps divert oxygenated blood from the inferior vena cava (ivc) towards the foramen ovale to bypass the pulmonary circulation.The ev is located in the superior portion of the ivc and protrudes into the right atrial cavity.After birth and subsequent closure of the foramen ovale, the valve has no particular function and regresses.There is a large variability in regards to shape, size, thickness, texture and length of this valve (1;2).In the above mentioned complaint, the patient suffered from a congenital heart disease; in patients with congenital heart disease, anatomic deviation very often does not only affect a single anatomic position, additional deviations in the anatomy of the heart and vessels do occur.In cases of congenital heart disease there is an enhanced probability of anatomic variations of the eustachian valve and there are a lot of diseases concerning the right atrium correlated to anatomical variations of this remnant valve (5;6;7).Echocardiography is a very well established method for diagnosis of every anatomical deviation of the heart and well established for the diagnosis of ev variations as well (8;9;10).Introduction of the avalon catheter follows a procedure derived from the placement of central venous lines using a guidewire prior to placement of the catheter itself as described by seldinger et al in 1953.In high risk patients it can be useful to use echocardiography for guidance of cannulae placement.Potentially deviating structures could be identified prior to initiating placement and real time ultrasound guidance during percutaneous cannulation helps to identify the guidewire in the ivc and can be very helpful to visualize all important structures under cannula introduction.This is especially the case in high risk procedures and in patients with congenital heart disease (11).According to the information gathered for this assessment cannula introduction was performed without echo-guidance and there is no information whether an echocardiography has been done to identify potentially hazardous deviations in the anatomy of the patient.Taken together, obviously a severe case of pericardium tamponade occurred after the avalon cannula had been placed; according to the autopsy an impairment of the eustachian valve was the probable cause for a massive bleeding leading to that tamponade.We do not have a complaint concerning malfunction or deviation of the avalon cannula.This is a tragic case of pericardium tamponade under ecmo.There is no product failure related to this tragic incident.Conclusion: based on the results and information available at this time the cause of the incident was determined to not be attributed to a device related malfunction.Corrective action: as a device related malfunction was not confirmed during investigation and no systemic issue could be determined no corrective action is needed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

(b)(4).

• Brand Name: CATHETER CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6145699
• MDR Text Key: 61458390
• Report Number: 8010762-2016-00705
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K081820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2016,11/28/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 10013 AVALON ELITE
• Device Catalogue Number: 701063529
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/16/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2016
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2016
• Date Device Manufactured: 10/01/2015
• 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): Death