PERFUSION SYSTEMS CARDIOBLATE; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING
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Model Number 49260 |
Device Problems
Material Puncture/Hole (1504); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/07/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been analyzed as it has not been returned.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 a cardioblate gemini-s device, the customer reported that the guide attachments broke.The broken pieces were not still attached to the guidewire.The physician had to remove the jaws from the patient and replace the device with a new device to complete the procedure.Additional information: the cable was not broken prior to use.The jaws of the cardioblate gemini-s device were clamped onto a surface just before starting the procedure, to check fluid irrigation.It was asked but is unknown how the broken pieces of the device were removed from the patient.The customer changed the position of the jaws twice in the procedure.
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Manufacturer Narrative
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Additional information received: the jaws of the cardioblate gemini-s device were clamped onto a surface just before starting the procedure, to check fluid irrigation.It was asked but is unknown how the broken pieces of the device were removed from the patient.Please pay attention to the methodology for performing the procedure.The doctor changed the position of the jaws twice in the procedure.Analysis of returned device confirms reason for return.Visual inspection confirms that a portion of the guide attachment on one of the jaws is damaged/missing.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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Manufacturer Narrative
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Correction mfg address correction device evaluated.Evaluation summary attached in h10 of previous report.Correction fdr updated.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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