PERFUSION SYSTEMS CARDIOBLATE; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING
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Model Number 49260 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2022 |
Event Type
Injury
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Manufacturer Narrative
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Device evaluation summary: visual inspection shows one of the jaw tips is broken off.Reason for return was confirmed.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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Medtronic received information that during use of the cardioblate gemini device, it was reported that the device was used to ablate 9 times on the right side of the heart in the concave position.When the device was pulled out of the chest to turn into a convex position and the surgeon was trying to unplug the device, one of the arms broke.The tip of the device was still attached to the guide.The surgeon feels that the joint where the device ends and the bulb is, is the weak point.The surgeon stated that they were very careful in removing the device from the guides and it still broke.The device was replaced.The customer reported that after 9 ablations the tip of the replacement device broke inside the patient.The tip remained attached to the guide but then came off but was able to be retrieved.The device was replaced to complete the procedure.There was no patient impact associated with this event.Medtronic received additional information that the devices inspected prior to use and no damage was noted.There were no damage to the packaging (outer box, inner packaging or sterile barrier).The issue with both cardioblate gemini devices occurred in the same procedure with the same patient.The tip was attached to the guide at first but then came off when the surgeon was trying to remove the guide.When the tip came off, the surgeon was able to retrieve with a minimally invasive grasper.
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Search Alerts/Recalls
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