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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 Device Contamination with Body Fluid (2317); Gas Leak (2946)
Patient Problems Embolism (1829); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059); Exit Block (2628)
Event Date 03/12/2020
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 inserting the balloon catheter into the sheath the back flow of blood was aspirated from the sideport of the sheath and more air was aspirated than usual. A slight st segment elevation was observed and the procedure was able to continue. Later the occlusion was attempted but unable to be performed and after deflating the balloon, a remarkable st segment elevation was observed and the patient's blood pressure decreased and a transient atrioventricular block developed. Medication was administered and intervention was performed. The case was aborted. A whole body computerized tomography (ct) scan was taken in addition to an magnetic resonance imaging (mri) of the head and no evidence of air was found; however, the physician stated air might have flown into the coronary artery. The patient's hospitalization was extended and they were discharged at a later date. 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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key9899435
MDR Text Key188332407
Report Number3002648230-2020-00187
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
Report Date 04/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/22/2021
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number0009974338
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2019
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: 03/30/2020 Patient Sequence Number: 1
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