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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 Low Blood Pressure/ Hypotension (1914); Great Vessel Perforation (2152); Cardiac Tamponade (2226)
Event Date 03/16/2018
Event Type  Injury  
Manufacturer Narrative
Product event summary: the data files were returned and analyzed. The data files showed at least five applications were performed with balloon catheter 2af283 with lot number 31325 without any issue on the date of the event. The sheath was not returned and there was no indication of a product malfunction. There were clinical issues (bp, tear in lspv, cardiac perforation and tamponade) encountered during the case. The reported clinical issues could not be confirmed through data analysis. 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 patient's blood pressure declined, and a cardiac tamponade was diagnosed. A pericardial drainage was performed, which removed a liter of blood. An open chest surgery was then performed, and a tear was found in the left superior pulmonary vein (lspv). The case was aborted, and the patient had an extended hospitalization. No further patient complications have been reported as a result of this event. Additional information reported that the patient is recovering and should have no further injuries other than the consequences of open chest surgery.
 
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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 Key7492314
MDR Text Key107532908
Report Number3002648230-2018-00293
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeFR
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 05/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot NumberUNKNOWN
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 Received04/11/2018
Was Device Evaluated by Manufacturer? Yes
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: 05/07/2018 Patient Sequence Number: 1
Treatment
MAPPING CATHETER, 990063-020
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