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

Model Number 4FC12

Device Problems Air Leak (1008); Fluid/Blood Leak (1250)

Patient Problems Air Embolism (1697); Bradycardia (1751); Cardiac Arrest (1762); ST Segment Elevation (2059); Ventricular Fibrillation (2130); Exit Block (2628)

Event Date 04/10/2017

Event Type  Injury  

Event Description

It was reported that during a cryo ablation procedure, after the sheath was positioned in the left atrium, a dilator was extracted and the sheath was flushed.Air continuously leaked and it was suspected that the hemostatic valve malfunctioned.While the sheath was replaced with a new one, electrocardiogram (ecg) identified st elevation.Atrial pacing was performed immediately however, atrioventricular block (av block) occurred.The patient¿s pulse stopped so rv pacing was performed.Additionally, air embolism was observed in right coronary angiograph (cag).Air was aspirated and nitro was given to the patient.Right coronary angiograph confirmed that blood flow restarted and rv pacing was thus stopped, however, ventricular fibrillation (vf) occurred and defibrillation was performed.It was noted that the patient temporarily reverted to sinus rhythm but bradycardia occurred and the patient¿s pulse stopped again.Rv pacing and air aspiration were performed again.When rv pacing was stopped, vf occurred.Defibrillation and rv pacing were performed once again.Then, rv pacing was stopped after for a while, the patient reverted to sinus rhythm.There was still air embolism shown partly in the left cag, air aspiration was performed and nitro was administered.It was further noted that the air embolism caused transient cardiac arrest.Ecg showed that the st gradually went down and blood pressure became stable.An intra-aortic balloon pump (iabp) was inserted and the patient left the operating room.The case was aborted without the use of general anesthesia.Post- procedure, the patient regained consciousness and could talk.The event led to extended hospitalization.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: upon visual inspection of flexcath sheath 4fc12 / 83516-079, results showed the stopcock was intact with no apparent issues.Air aspiration was reproduced when a test arctic front catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking; valve was torn.Arrhythmia, heart block, embolism, cardiac arrest or cardiopulmonary arrest and st elevation are clinical issues encountered during the procedure.In conclusion, the reported issue (air ingress) has been confirmed through testing.The sheath failed the returned product inspection due to a leaking hemostatic valve.Arrhythmia, heart block, embolism, cardiac arrest or cardiopulmonary arrest and st elevation are clinical issues encountered during the procedure.

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; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6549324
• MDR Text Key: 74580919
• Report Number: 3002648230-2017-00205
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2018
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 83516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2016
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention