Concomitant devices: swartz introducer, brk transseptal needle.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
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Related manufacturing ref: 3005334138-2021-00053, 3008452825-2021-00052.The following was published in the journal of innovations in cardiac rhythm management, titled "safety and efficacy of minimal- versus zero-fluoroscopy radiofrequency catheter ablation for atrial fibrillation: a multicenter, prospective study" by paul c.Zei, et al.: acute procedural complications occurred in three patients (1.8%), including one case of transient ischemic attack, one case of groin hematoma, and one case of pericardial effusion without hemodynamic effect, all of which were managed conservatively.
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