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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 Air Leak (1008)
Patient Problem ST Segment Elevation (2059)
Event Date 09/05/2017
Event Type  malfunction  
Manufacturer Narrative
Product event summary: data files were returned and analyzed. Data files showed that at least twelve applications were performed with the balloon catheter without any issue on the date of the event. However, multiple injections were non-sustained. St elevation occurred during the thawing phase of the procedure. Coronary angiography was performed, and no air was confirmed. The sheath was not returned for investigation. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cryoablation procedure, st elevation occurred during the thawing phase. Coronary angiography was then performed, and no air was confirmed. After a few minutes, the st elevation recovered. The balloon catheter was then extracted from the patient's body in order to remove air. The procedure continued, and the case was completed with cryo. It was noted that the suspected cause of the st elevation was air ingress on the sheath, as the hemostatic valve was open. 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 Key6895181
MDR Text Key105814934
Report Number3002648230-2017-00535
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 11/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/09/2019
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number08055
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 Received10/13/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/09/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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