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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 Gas Leak (2946); Material Integrity Problem (2978)
Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Death (1802); ST Segment Elevation (2059); Ventricular Fibrillation (2130); Brain Injury (2219); Loss of consciousness (2418)
Event Date 08/02/2018
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, while the balloon catheter was being inserted into the sheath, the patient took a deep breath. A large amount of air was aspirated. St elevation was then observed and a backflow of blood was confirmed. The patient developed ventricular fibrillation (vf) and defibrillation was administered. The patient then went into cardiac arrest. A coronary angiogram was performed and air embolism was confirmed in the coronary artery and part of the aorta. Percutaneous cardiopulmonary support (pcps) was then attached to the patient. The patient remained unconscious. The patient left the operating room and was brought to an intensive care unit for further observation. It was indicated that the heart rate stabilized. The case was aborted and the patient was not under general anesthesia. It was further indicated that the patient has severe brain damage. The physician felt that the valve of the sheath was not as expected. Further information received indicated that the patient is off the pcps, but is suffering "grave" damage to the brain and was still being hospitalized. Additional information reported that the patient passed away.
 
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, while the balloon catheter was being inserted into the sheath, the patient took a deep breath. A large amount of air was aspirated. St elevation was then observed and a backflow of blood was confirmed. The patient developed ventricular fibrillation (vf) and defibrillation was administered. The patient then went into cardiac arrest. A coronary angiogram was performed and air embolism was confirmed in the coronary artery and part of the aorta. Percutaneous cardiopulmonary support (pcps) was then attached to the patient. The patient remained unconscious. The patient left the operating room and was brought to an intensive care unit for further observation. It was indicated that the heart rate stabilized. The case was aborted and the patient was not under general anesthesia. It was further indicated that the patient has severe brain damage. The physician felt that the valve of the sheath was not as expected. No further patient complications have been reported as a result of this event. (b)(6)2018: further information received indicated that the patient is off the pcps, but is suffering "grave" damage to the brain and is still being hospitalized. (b)(6)2018: additional information reported that the patient passed away. (b)(6)2018: incoming information indicated that the date of the death has not been disclosed.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key7833926
MDR Text Key118797696
Report Number3002648230-2018-00596
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
Type of Report Initial,Followup,Followup
Report Date 05/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/17/2020
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number41670
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/18/2018
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: 08/30/2018 Patient Sequence Number: 1
Treatment
2AF284 BALLOON CATHETER
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