MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Model Number 2AF284 |
Device Problems
Flushing Problem (1252); Leak/Splash (1354); Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2024 |
Event Type
malfunction
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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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Event Description
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It was reported that during a cryo ablation procedure, aspiration was unable to be performed.Negative pressure was applied, but air continued to be drawn.The balloon catheter was removed and prepped again without resolution.Several attempts to aspirate were performed unsuccessfully.The balloon catheter was removed again and bulging in the adhesive area between the tip and balloon on the distal side of the balloon catheter was observed.It was surmised that this bulging may have occluded the sheath, making aspiration difficult.The balloon catheter was replaced which resolved the issues.The case was completed with cryo. 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 2af284 balloon catheter with lot number 10256 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 downloaded and reviewed.Data indicated the catheter was used for four applications on the reported event date.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 were in range and temperature curve had no oscillation or overshoot.During device compatibility inspection (balloon catheter insertion into sheath), the outer balloon distal bond diameter was measured out of specification.The outer balloon distal bond measured 0.164 inches (specification is >0.157inch).The user may experience insertion into the sheath and also flushing and purging air from the sheath difficulties due to this issue.In conclusion, the reported air ingress issue could not be confirmed.The balloon catheter failed the return pro duct inspection due to the outer balloon distal joint outer diameter being out of specification 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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