MEDTRONIC MEXICO S. DE R.L. DE CV ACHIEVE MAPPING CATHETER - 15 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
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Model Number 990063-015 |
Device Problems
Compatibility Problem (2960); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/02/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product event summary: the 990063-015 mapping catheter with lot number 225876810 was returned and analyzed.Visual inspection of the loop segment area showed the loop was intact with no apparent issues.No damage was observed along with the tip/loop section of the mapping catheter.Visual inspection of the pebax segment area showed the pebax tubing at the shaft fitting joint was damaged/kinked.Visual inspection of the electrodes showed the electrodes were intact with no apparent issues.All electrodes exist on the loop section and no cosmetic issue or anomalies were identified.The shaft segment area showed the shaft was intact with no apparent issues.No kink or any other damage was observed along with the shaft of the mapping catheter.The introducer was intact with no apparent issues.No damage or any other issue was observed along with the introducer.Visual inspection of the lemo connector showed the lemo connector was intact with no apparent issues.No damage or any other issue was observed along with the lemo connector.Compatibility testing with the balloon catheter was unable to be performed due to the pebax tubing to the shaft bond can't pass through the introducer hub.In conclusion, the reported compatibility issue was confirmed and the mapping catheter did not pass the returned product inspection due to bond damage at the shaft to the pebax tube fitting.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 have not 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, the balloon catheter was exchanged for a larger balloon, and when the mapping catheter was reinserted, it would not advance through the balloon catheter.The mapping catheter was replaced which resolved the is sue. the case was completed with cryo. no patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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