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Model Number 4FC12 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Hematoma (1884)
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Event Date 12/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical product: arctic front advance cardiac cryoablation catheter.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.Patient information is limited due to confidentiality concerns.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique lot numbers.The model listed in the report is a representative of the model family, as there is no specific model listed.The baseline gender/age of the patients represented in the article is male/56 years old.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: ¿time-to-effect¿based dosing strategy for cryoballoon ablation in patients with paroxysmal atrial fibrillation results of the plusone multicenter randomized controlled noninferiority trial.¿ circ arrhythm electrophysiol.2017;10:e005318.Doi: 10.1161/circep.117.005318.Clinical trial information: url: https://clinicaltrials.Gov.Unique identifier: (b)(4).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 complications while using a cryoablation balloon/sheath catheter/mapping catheter: there was one patient who presented pericardial effusion with tamponade, which required pericardiocentesis for resolution.There were five (5) patients with transient phrenic nerve palsy (pnp); four of which recovered "immediately," and one before hospital discharge.There was one (1) patient who experienced a transient ischemic attack (tia), with unknown treatment/resolution.There were two (2) patients with transient st segment elevation, with unknown treatment/resolution.There was one (1) patient who had an "uncomplicated" hematoma, with unknown treatment/resolution.There was one (1) patient who had a femoral pseudoaneurysm, 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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