MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

Device Problem Air Leak (1008)

Patient Problems Air Embolism (1697); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Pain (1994); ST Segment Elevation (2059); Heart Failure (2206); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a cryo ablation procedure, the patient experienced pain.The patient¿s blood pressure was observed with no concerns and an additional bolus of fentanyl and heparin were given.At the end of the ablation, the patient¿s blood pressure had decreased; it was noted that, ¿the range of the values were seen before the first application¿.The procedure was continued until the patient¿s blood pressure could not be measured non-invasively.The physician reported, ¿no invasive blood pressure monitoring was in place, and at this stage an arterial cannulation was not possible¿.An x-ray was performed and an opaque, dilated pericardial space was observed and a cardiac tamponade was suspected.An emergency echocardiogram was performed and the cardiac tamponade was confirmed.Protamin was administered and an emergency pericardial puncture was conducted.A drain was inserted and blood was extracted.The patient¿s blood pressure improved slightly; however, the ecg revealed that the pericardial effusion had not resolved.The emergency cardiac surgical team was notified and a decision to perform an emergency sternotomy was performed.It was noted that mechanical resuscitation was required for approximately five minutes due to progressive bradycardia until the arrival of the surgical team.Open heart surgery was conducted and the pericardial effusion was drained and a cardio-pulmonary bypass was installed.Exploration of the heart revealed a perforation to the left superior pulmonary vein (lspv), which was closed by the cardiac surgeon.However, an intermittent st-elevation was observed.A transesophageal echocardiogram (tee) was conducted that observed no regional wall motion abnormalities, but there was a significant amount of air in the left pulmonary vein (lpv).A large part of the air was released through the ventricular wall and the patient¿s st segment elevation resolved.The patient was disconnected from the cardiopulmonary bypass and the chest was closed.However, severe right-heart failure occurred, requiring emergent re-opening of the chest and re-installation of the cardiopulmonary bypass.After cardiopulmonary bypass and continuous severely impaired bi-ventricular function, it was decided to leave the chest open and to install an extracorporeal membrane oxygenation (ecmo).The patient was then transferred to the surgical intensive care unit with the ecmo in place and hemodynamically stable.It was further reported that the patient was still in recovery five days after the procedure and the patient¿s chest remains open.The physician reported that, ¿weaning of the ecmo is completed half way and the ecmo can hopefully be removed soon¿.The patient¿s other organs were stable and neurologically the patient has opened their eyes and was following commands and moving all extremities.The physician also reported that the patient had been taken off the ventilation and ecmo.The patient has no permanent injury and is cardiologically and neurologically in good shape.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files did not show system notices or issues for the date of the event.Physical product analysis is pending.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the sheath was visually inspected and functionally tested.Visual inspection of the sheath showed the stopcock was intact with no apparent issues.Air aspiration was reproduced when a test catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking; the valve was torn.Clinical data files were reviewed and did not show system notices or issues for the date of event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6128901
• MDR Text Key: 60941021
• Report Number: 3002648230-2016-00500
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2018
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 01215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2016
• 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
• Treatment: 4FC12, (B)(4)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR