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Model Number 4FC12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Vascular System (Circulation), Impaired (2572); Pseudoaneurysm (2605); Pericardial Effusion (3271)
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Event Date 01/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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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 70 years old.
The baseline weight of the patients involved is 64 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: limited efficacy of a figure-of-eight suture for hemostasis after cryoballoon atrial fibrillation ablation with uninterrupted oral anticoagulants.
J cardiol (2020), https://doi.
Org/10.
1016/j.
Jjcc.
2020.
01.
012.
If information is provided in the future, a supplemental report will be issued.
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Event Description
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The literature publication reported the following patient complication during the use of a cryoballoon ablation catheter and sheath.
There were two (2) patients who experienced pericardial effusions; however, no sign of cardiac tamponade was observed, and they did not require a pericardiocentesis.
There were 31 patients with bleeding at the puncture site; out of this group there were two (2) patients with ¿major¿ bleeding.
In addition, there were two (2) patients who had pseudoaneurysms; one required surgical intervention and a blood transfusion, and the other one was treated with manual compression and an injection of thrombin.
These occurred at six and seven days after the procedure, respectively.
Of note, multiple patients/methods/manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.
The status/location of the cryoballoon catheter and sheath 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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Search Alerts/Recalls
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