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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 Problem Cardiovascular Insufficiency (4445)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
This information is based entirely on journal literature. Medtronic was made aware of this event through a search of literature publications. This event occurred outside the us. Patient information is limited due to confidentiality concerns. Of note, multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique product serial/lot numbers. The baseline gender/age characteristics is male/63 years old. The model listed in the report is a representative of the model family, as there is no specific model listed. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: long-term outcomes of index cryoballoon ablation or point-by-point radiofrequency ablation in patients with atrial fibrillation and systolic heart failure. Journal of cardiovascular electrophysiology. 2021;32:941¿948. Doi: 10. 1111/jce. 14923 if information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article was reviewed that contained information regarding cryoballoon ablation. The article reports two patients who experienced vascular complications which required intervention or blood transfusion. The status/disposition of the sheaths is unknown. No further patient complications have been reported as a result of this event. Further follow up did not yet yield any additional information.
 
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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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key14043800
MDR Text Key288807422
Report Number3002648230-2022-00149
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 04/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/24/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 04/07/2022 Patient Sequence Number: 1
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