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

Model Number 4FC12

Device Problems Air Leak (1008); Material Integrity Problem (2978)

Patient Problems Air Embolism (1697); Bradycardia (1751); Infarction, Cerebral (1771); Death (1802); ST Segment Elevation (2059); Cardiac Tamponade (2226); Loss of consciousness (2418)

Event Date 09/29/2017

Event Type  Death  

Manufacturer Narrative

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.

Event Description

It was reported that during a cryo ablation procedure, air was confirmed in both the coronary sites as well as a large amount where the pulmonary artery divides from the right ventricular outflow tract (rvot).Air was also observed in the left ventricle.According to the physician, ¿it is highly likely that the event was caused when the catheter was inserted into the sheath while an attempt was made to reinsert the sheath into the left atrium.The air ingress was not due to the insertion itself, but the patient taking deep breaths, causing negative pressure that pulled in the air through the gap between the hemostatic valve and the catheter." contrast x-ray images were performed after the transseptal puncture.When the balloon catheter was inserted into the sheath, more air than usual was observed during aspiration.After the balloon catheter was placed on the right inferior pulmonary vein (ripv), the sheath dislodged into the right atrium.It was suggested to use a different sheath, however, the physician proceeded.When the catheter was inserted, a large amount of air was continuously removed through the sheath side port.Five syringes were used before the air stopped.Additionally, a continuous drip was being performed using a competitor cool point irrigation pump.It was suggested to the physician to stop the drip while approaching the left atrium, to avoid the risk of air flowing into the patient¿s body, however, the drip was continuously used.The competitor catheter failed to re-insert into the sheath.No abnormal amount of air was observed at that time.The ablation catheter also failed to re-insert into the sheath while in the left atrium.Next, the sheath dilator and a guidewire were inserted in the sheath to attempt approaching the left atrium but this also failed.The dilator was removed from the sheath.While the operator considered another approach, aspiration was performed from the sheath side port, without any issues.It was decided to replace the sheath and st elevation occurred.Furthermore, bradycardia occurred.The procedure was immediately aborted and a coronary angiography (cag) was performed by the designated ischemia team.Air was apparent in the right cag.After cag, air was removed using a catheter and balloon pump as well as temporary pacemaker was used.It was confirmed that air was in the right pulmonary artery, the left ventricle, and the coronary artery.Mri scan was not performed since the temporary pacemaker was used.Air in the brain was also confirmed by ct scan.The patient remained unconscious in the intensive care unit.After the examination at the facility, the sheath tip was covered and aspiration was tested using saline.Air ingress was noted through the hemostatic valve.Further information reveals that the patient deceased the following day.

Manufacturer Narrative

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

Event Description

It was further reported that when the sheath was pulled into the right atrium, and an attempt was made "to reposition using the tip of the balloon resulted in tamponade".

Manufacturer Narrative

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

Manufacturer Narrative

Product event summary: the sheath, 4fc12 with lot number 14983 was analyzed.Visual inspection of the sheath showed the shaft was kinked at 21mm and 55mm proximal from the tip which may have been caused post-procedure.Aspiration/ flushing test did not show any air passing through the tube or expelled from the sheath distal tip.Multiple aspirations / injections were performed without air bubbles or leaks through the hemostasis valve when a test arctic front catheter was introduced through the sheath.Hemostasis valve was leak tight.Dissection of the sheath handle did not show any anomaly in adhesive application.The hemostasis valve was inspected under microscope, no anomaly has been observed.Additionally, known clinical issue (embolism, st elevation, arrhythmia) were encountered during the procedure.In conclusion, the reported air ingress issue was not confirmed through testing.The sheath passed the product inspection.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

It was reported that during a cryo ablation procedure, air was confirmed in both the coronary sites as well as a large amount where the pulmonary artery divides from the right ventricular outflow tract (rvot).Air was also observed in the left ventricle.According to the physician, ¿it is highly likely that the event was caused when the catheter was inserted into the sheath while an attempt was made to reinsert the sheath into the left atrium.The air ingress was not due to the insertion itself, but the patient taking deep breaths, causing negative pressure that pulled in the air through the gap between the hemostatic valve and the catheter." contrast x-ray images were performed after the transseptal puncture.When the balloon catheter was inserted into the sheath, more air than usual was observed during aspiration.After the balloon catheter was placed on the right inferior pulmonary vein (ripv), the sheath dislodged into the right atrium.It was suggested to use a different sheath, however, the physician proceeded.When the catheter was inserted, a large amount of air was continuously removed through the sheath side port.Five syringes were used before the air stopped.Additionally, a continuous drip was being performed using a competitor cool point irrigation pump.It was suggested to the physician to stop the drip while approaching the left atrium, to avoid the risk of air flowing into the patient¿s body, however, the drip was continuously used.The competitor catheter failed to re-insert into the sheath.No abnormal amount of air was observed at that time.The ablation catheter also failed to re-insert into the sheath while in the left atrium.Next, the sheath dilator and a guidewire were inserted in the sheath to attempt approaching the left atrium but this also failed.The dilator was removed from the sheath.While the operator considered another approach, aspiration was performed from the sheath side port, without any issues.It was decided to replace the sheath and st elevation occurred.Furthermore, bradycardia occurred.The procedure was immediately aborted and a coronary angiography (cag) was performed by the designated ischemia team.Air was apparent in the right cag.After cag, air was removed using a catheter and balloon pump as well as temporary pacemaker was used.It was confirmed that air was in the right pulmonary artery, the left ventricle, and the coronary artery.Mri scan was not performed since the temporary pacemaker was used.Air in the brain was also confirmed by ct scan.The patient remained unconscious in the intensive care unit.After the examination at the facility, the sheath tip was covered and aspiration was tested using saline.Air ingress was noted through the hemostatic valve.Further information reveals that the patient died the following day.

• 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: 6949395
• MDR Text Key: 89305493
• Report Number: 3002648230-2017-00561
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 14983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2017
• 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: 2AF284 CATHETER
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR