Model Number 4FC12 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Blood Loss (2597); Pericardial Effusion (3271)
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Event Date 01/01/2016 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant product: achieve mapping catheter.Medtronic cryocath 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.The event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.The baseline gender/age characteristic is male/(b)(6) for the patients referenced in the article.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.Referenced article: ¿reduction of radiation exposure in cryoballoon ablation procedures: a single-centre study applying intracardiac echocardiography and other radioprotective measures.¿ europace.Doi:10.1093/europace/euw139.
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Event Description
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The literature publication reports the following patient complication while using a sheath catheter: there was one (1) patient who experienced pericardial effusion.The status/location of the sheath catheter is unknown.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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 reports the following patient complication while using a sheath catheter: there were three (3) patients who had "major bleeding from the puncture site," with unknown treatment/resolution.The status/location of the sheath catheter is unknown.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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