MPRI ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
|
Back to Search Results |
|
Model Number AFAPRO28 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)
|
Patient Problem
Hemorrhage/Bleeding (1888)
|
Event Date 12/12/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
Product event summary: the afapro28 balloon catheter with lot number 11982 was returned and analyzed.No anomalies were identified during external visual inspection of the balloon, shaft, and handle segments.The catheter smart chip data was reviewed.The data indicated the catheter was never used (no application performed).The catheter was recognized and passed the electrical integrity verifications and performance test.The catheter completed the inflation, ablation, and thawing phases with no console system notices generated.No performance issues were identified.All pressure and flow values were in range and the temperature curve had no oscillation or overshoot.In conclusion, the reported clinical issue (bleeding) occurred during the procedure and the decision to abort the procedure without use of alternate therapy was based upon the medical judgement of the physician.There is no indication of a relation of the adverse events to the performance and malfunction of the product.The balloon catheter did not fail the returned product inspection and the reported "catheter not recognized" system notice was not observed nor reproduced during testing.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.
|
|
Event Description
|
It was reported that during a cryo ablation procedure, the catheter could not be recognized.The auto connection box, coaxial umbilical cable, and electrical umbilical cable were reconnected and replaced without resolution.Subsequently, the balloon catheter was r eplaced which resolved the issue.It was also reported that during the left atrial portion of the procedure, the patient exhibited blood in the endotracheal (et) tube.The anticoagulant was reversed with anticoagulant-antagonist medication.The case was aborted while the patient was under general anesthesia.The cause of blood in the et tube was undetermined, but it was surmised that intubation or the transesophageal echocardiogram (tee) may have caused or contributed to the adverse event. no further patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
Product event summary: the data files were returned and analyzed.One patient file was received and recorded on the reported date of the event.The failure file was not received.The patient file showed 10 applications were performed using an afapro28 balloon catheter with lot number 11982.The patient file did not show any system notice on the reported date of the event.In conclusion, the report catheter recognition issue could not be assessed through data analysis.The clinical issue of bleeding occurred during the procedure and the decision to abort the procedure without use of alternate therapy was based upon the medical judgement of the physician.There is no indication of a relation of the adverse event to the performance or 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.
|
|
Search Alerts/Recalls
|
|
|