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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Event Date 03/03/2022
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 cryoablation procedure, the system was aspirated, then inserted into the left atrium. The first pulmonary vein (pv) was cannulated, the balloon catheter was inflated and contrast was injected to check the occlusion, however there was an anomalous dispersion of the contrast so the system was removed and an echocardiogram confirmed a pericardial effusion that developed into a tamponade. The patient also became hypotensive.   the case was aborted while the patient was under general anesthesia. A coagulant was administered and a pericardiocentesis was performed draining two liters of blood. The patient went into cardiac arrest multiple times. It was determined that the patient required thoracic surgery. Upon transfer to surgery, the patient went into cardiac arrest and required a cardiac massage until surgery could be performed. The patient returned to spontaneous rhythm with a normal blood pressure. In surgery, a perforation was found on the upper portion of the left atrium, which was then surgically closed. The patient was taken to the intensive care unit (icu) for recovery. Upon waking up, the patient maintained normal cognitive abilities.  no further patient complications have been reported as a result of this event.
 
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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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13711601
MDR Text Key286866085
Report Number3002648230-2022-00095
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number0010946221
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/03/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/23/2021
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: 03/09/2022 Patient Sequence Number: 1
Treatment
AFAPRO28 BALLOON CATHETER, 2ACH20 MAPPING CATHETER
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