MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Model Number 2AF284 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/03/2021 |
Event Type
Death
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Event Description
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A journal article was reviewed that contained information regarding cryoballoon ablation.The article reports patient deaths in the follow up period post ablation procedure.The causes of the deaths are unknown.The status/disposition of the catheters is unknown.There is no allegation of ablation procedure-death relatedness indicated in the article; however, the cause of death and relatedness has been requested, but not yet received.
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Manufacturer Narrative
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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/ (b)(6)years old.The model listed in the report is a representative of the model family, as there is no specific model listed.The date of death is not available at the time of this report as there is no indication of specific serial number/patient information.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: different determinants of the recurrence of atrial fibrillation and adverse clinical events in the mid-term period after atrial fibrillation ablation.Circulation journal.2022; 86:233-242.Doi: 10.1253/circj.Cj-21-0326.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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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.The date of death is not available at the time of this report as there is no indication of specific serial number/patient information.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: different determinants of the recurrence of atrial fibrillation and adverse clinical events in the mid-term period after atrial fibrillation ablation.Circulation journal.2022; 86:233-242.Doi: 10.1253/circj.Cj-21-0326.If information is provided in the future, a supplemental report will be issued.
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Event Description
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A journal article was reviewed that contained information regarding cryoballoon ablation.The article reports patient deaths in the follow up period post ablation procedure.The causes of the deaths are unknown.The status/disposition of the catheters is unknown.There is no allegation of ablation procedure-death relatedness indicated in the article; however, the cause of death and relatedness has been requested, but not yet received.
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