MEDTRONIC MEXICO S. DE R.L. DE CV ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
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Model Number 990063-020 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/11/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a cryo ablation procedure, the mapping catheter was difficult to maneuver.Resistance was felt when removing the mapping catheter from the balloon catheter after the case, and when the mapping catheter was removed it was observed electrodes had detached and were stuck inside the balloon catheter distal shaft.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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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 990063-020 mapping catheter with lot 223679184 was returned and analyzed.The mapping catheter loop tip was received inserted and stuck inside the balloon catheter.It was not possible to retract the mapping catheter tip.Additional x ray imaging showed that all the electrodes were stuck inside the guide wire lumen of the balloon catheter.In conclusion, the reported electrode detachment was confirmed through testing.The mapping catheter failed the returned product inspection due to detached electrodes/tip and detached pebax tubing.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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Search Alerts/Recalls
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