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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 Gas/Air Leak (2946)
Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); Cyanosis (1798); Embolism (1829); Neurological Deficit/Dysfunction (1982); ST Segment Elevation (2059); Vascular System (Circulation), Impaired (2572); Exit Block (2628)
Event Date 11/04/2019
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, the sheath was difficult to introduce. A smaller caliber introducer was used to predilate. When advancing the balloon catheter the patient suffered a complete blockage and stimulation was used to recover the normal sinus rhythm. The patient showed high st elevation, cyanosis symptoms and didn't respond to any stimulus. The procedure was aborted and an air thromboembolism was confirmed over the full right coronary artery. Ecmo (extracorporeal membrane oxygenation) was initiated. During the patient stimulation the doctors became aware the patient suffered a mechanical block; it was noted the patient went into cardiac arrest, and cardiopulmonary resuscitation (cpr) was started. The patient then went into ventricular fibrillation (vf) and two external defibrillator socks were necessary to bring the patient back to a normal sinus rhythm. A second diagnostic coronary catheterization was performed to confirm the embolism was not longer present, and a venous return aortic balloon was placed to promote ventricular function. The patient remains hospitalized with severe neurological problems. No further patient complications have been reported as a result of this event. Additional incoming information indicated the patient suffered a complete block produced by an air thromboembolic collapse of the coronary arteries. The patient had brain damage produced by the thromboembolic air obstruction of brain arteries and their current status is 'critical. ' it was noted the mapping catheter was inside the balloon catheter at the time of the initial blockage that occurred during the balloon advance.
 
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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 Key9367547
MDR Text Key184905970
Report Number3002648230-2019-00798
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeSP
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
Report Date 11/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/10/2021
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number0009899374
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 Received11/04/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/11/2019
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: 11/24/2019 Patient Sequence Number: 1
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