MEDTRONIC, INC. ACHIEVE ADVANCE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
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Model Number 2ACH20 |
Device Problems
Material Deformation (2976); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2024 |
Event Type
malfunction
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Event Description
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It was reported that during a cryo ablation procedure, after inflation was performed and the right superior pulmonary vein (rspv) was frozen.The mapping catheter shaft inside the balloon catheter was slightly curved under imaging. the case was completed with cryo.After the case, the mapping catheter was removed and it was confirmed that the mapping catheter tip was kinked. no patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Manufacturer Narrative
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Product event summary: the 2ach20 mapping catheter with lot number 8812882 was returned and analyzed.Visual inspection of the shaft segment area showed the shaft was kinked approximately 57.6 inches from the lemo connector.The functional test was performed and the continuity and impedance measurement between the electrodes and the other side of the cable showed the electrode's continuity and impedance to the cable are normal.In conclusion, the reported kink issue was confirmed and the mapping catheter failed the returned product inspection due to a shaft kink.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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