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U.S. Department of Health and Human Services

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

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MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE Back to Search Results
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  
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, 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.
 
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Brand NameFLEXCATH ADVANCE STEERABLE SHEATH
Type of DeviceCATHETER, 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 Key6549324
MDR Text Key105780670
Report Number3002648230-2017-00205
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K123591
Number of Events Reported1
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 Received05/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/08/2018
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number83516
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/05/2017 Patient Sequence Number: 1
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