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Model Number 4FC12 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Cardiac Tamponade (2226)
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Event Date 01/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of medical devices: achieve mapping catheter.Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific patient or 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.Patient information is limited due to confidentiality concerns.The model listed in the report is a representative of the model family, as there is no specific model listed.The gender of the baseline characteristics is male and the baseline age is (b)(6).Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.Without a lot number or device serial number, the manufacturing date cannot be determined.Referenced article: chromosome 4q25 variants and recurrence after second-generation cryoballoon ablation in patients with paroxysmal atrial fibrillation.¿ international journal of cardiology 244 (2017) 151¿157.Http://dx.Doi.Org/10.1016/j.Ijcard.2017.06.046.
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Event Description
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The literature publication reports the following patient complication while using a cryoablation balloon/sheath catheter/mapping catheter: there was one patient who experienced cardiac tamponade, which required pericardiocentesis.There were three (3) patients who experienced phrenic nerve injury (pni) which remained on the day after the procedure, with unknown treatment/resolution.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.The status/location of the cryoballoon/sheath catheter/mapping catheter is unknown.No further patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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