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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 Perforation (2001); Transient Ischemic Attack (2109); Cardiac Tamponade (2226); Cardiac Perforation (2513); Blood Loss (2597); No Code Available (3191); Pericardial Effusion (3271)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Medtronic was made aware of this event through a search of literature publications. It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events. This information is based entirely on journal literature. This event occurred outside the us. All information provided is included in this report. Of note, multiple patients/multiple methods/multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers/methods/manufacturers. The overall baseline gender characteristics is male; the age of the patients was approximately 64 years old, and the baseline weight of the patients was 65 kgs. 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: ¿periprocedural management of cardiac tamponade during catheter ablation for af under uninterrupted doac and warfarin. ¿ jacc: clinical electrophysiology. 2020; 6(7):786-795. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The literature publication reported the following patient complications during a procedure using a cryoballoon ablation catheter system. Of note, multiple patients/multiple methods/multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers/methods/manufacturers. There were patients who experienced cardiac tamponade, pericardial effusion, and bleeding. There was one (b)(6)-year-old male cryoballoon patient (patient #13), who also had a ¿tear¿ within the carina of the right pulmonary vein; which, according to the author was ¿caused by the sheath injury. ¿ the surgery for this patient was "successful," however, the patient was transferred to a care center after discharge, due to decreased physical activity. Surgical intervention, including pericardiocentesis, and infusion of protamine, drains placed, and blood transfusions were performed as part of the treatment for these patients. The status/location of the cryoballoon catheter system is unknown. Further follow up did not yet yield any additional information. 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 Key10544016
MDR Text Key207302459
Report Number3002648230-2020-00488
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 foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 09/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
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 Received08/17/2020
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: 09/16/2020 Patient Sequence Number: 1
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