MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Model Number AFAPRO28 |
Device Problems
Compatibility Problem (2960); Material Integrity Problem (2978); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/30/2024 |
Event Type
Injury
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Manufacturer Narrative
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Product id: 2ach20 product type: mapping catheter 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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Event Description
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It was reported that during a cryo ablation procedure, it was difficult accessing and occluding the right superior pulmonary vein (rspv).It was then reported that the mapping catheter became stuck in the entrance of the balloon catheter.It was then reported that an unknown system notice was received indicating an issue with the balloon integrity.The catheters were removed and the case was aborted while the patient was under general anesthesia. no patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the afapro28 balloon catheter with lot number 20035 was returned and analyzed.External visual inspection of the balloon segment showed blood inside the balloon.The catheter smart chip data was downloaded and reviewed.Data indicated the catheter was used for 9 applications on the reported event date.During functional testing, the console terminated the application and triggered system notice 50005 "the safety system detected fluid in the catheter and stopped the injection." the insertion of the mapping catheter was blocked inside the balloon catheter due to the guide wire lumen kink inside the balloon segment.Pressure testing and inspection of sub-components was performed on the balloon, handle, and shaft segments.During inspection and pressure testing of the shaft segment, a guide wire lumen kink and breach was observed at 0.75 inches and 1.20 inches proximal to the catheter tip.During inspection of the handle segment, blood / liquid was observed inside handle.In conclusion, the balloon catheter failed the returned product inspection due to the guide wire lumen kink and breach.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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