MEDTRONIC, INC. ACHIEVE ADVANCE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
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Model Number 2ACH20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 09/15/2023 |
Event Type
Injury
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Event Description
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It was reported that during a cryo ablation procedure, while maneuvering in the left superior pulmonary vein (lspv), the physician noted a clot on the mapping catheter.Without further movement of the mapping catheter, the clot broke off.It was of note that an anticoagulant had been administered shortly after transeptal access.The case was aborted. no further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Continuation of d10: product id 4fc12 (0011816352); product type: 0629-flexcath sheath; implant date: n/a; explant date: n/a, product id: afapro28 (09048); product type: 0624-arctic front catheter; implant date: n/a; explant date: n/a.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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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Manufacturer Narrative
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Product event summary: the data files and the 2ach20 mapping catheter with an unknown lot number were returned and analyzed.The patient file showed five applications were performed using an afapro28 balloon catheter with lot number 09048.The patient data file showed system notice 50012 (the refrigerant delivery path is obstructed) during the transition phase at applications one and two.The received failure file contained failure records for the date of the event.The failure file showed system notice 50012 (the refrigerant delivery path is obstructed) on the reported date of the event.Two image files were received as part of the returned data files and showed the balloon catheter and mapping catheter inside of the patient.Visual inspection of the mapping catheter was performed and the mapping catheter was intact with no apparent issues.No kinks were observed along with the shaft, pebax or tip/loop section of the mapping catheter.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 were normal.In conclusion, the reported clinical issue (clot) occurred during the procedure.The mapping catheter passed the returned product inspection as per specification.There is no indication of a relation of the adverse event to the performance and malfunction of the product.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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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