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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 Cardiopulmonary Arrest (1765); Vascular Dissection (3160); Pericardial Effusion (3271)
Event Date 12/14/2017
Event Type  Injury  
Manufacturer Narrative
Product event summary: the data files were returned and analyzed. The data files did not show any system notice for the date of the event. The sheath was not returned and there was no indication of a product malfunction. Some known clinical issues (cardiac perforation, pericardial effusion, tamponade and pulmonary vein tear) were encountered during the procedure. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received indicated that during the open chest thoracotomy, a pulmonary vein (pv) tear was found and repaired. Additionally, the patient has since been discharged home.
 
Event Description
It was reported that during a cryo ablation procedure, the patient had a pericardial effusion, which was confirmed via intracardiac echocardiography (ice). The case was aborted, and the patient was under general anesthesia. Subsequently, the patient required cardiopulmonary resuscitation (cpr), and open chest thoracotomy. The patient was then transported to the operating room (or) for a subsequent procedure or surgery. The patient's hospitalization was extended. The patient is recovering, and the extent of permanent injuries were unable to be determined. 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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7139815
MDR Text Key105889230
Report Number3002648230-2017-00715
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/11/2019
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number58287
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 Received12/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/11/2017
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: 12/21/2017 Patient Sequence Number: 1
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