Model Number SG-64 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Other relevant device(s) are: product id: s g-64, serial/lot #: (b)(4), ubd: 13-oct-2021, udi#: (b)(4); product id: sg-64, serial/lot #: (b)(4), ubd: 27-apr-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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3 heli-fx guides were intended to be used in an endovascular procedure.It was reported when these guides were taken out of the packaging, an unknown white powder was present along the distal shafts of all the guides.The use of these guides was abandoned due to the concern of the sterility of these devices.As per the physician the cause of the event can not be determined.No additional clinical sequalae were provided and the patient is fine.
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Manufacturer Narrative
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Product analysis: a slightly whitish appearance was observed on the surface of the catheter extending from the tip to 36.2cm from the end of the handle and 3.0cm from the distal end of the tip.There was no evidence of a residue on the surface of the catheter.Device decontaminated with cidex-opa pending further device testing to support the final product analysis findings.The slightly whitish appearance remained on the surface of the catheter.Analysis of the returned guide did not detect a foreign material on the surface of the guide.Product analysis: a slightly whitish appearance was observed on the surface of the catheter extending from the tip to 36.0cm from the end of the handle and 2.9cm from the distal end of the tip.There was no evidence of a residue on the surface of the catheter.Device decontaminated with cidex-opa pending further device testing to support the final product analysis findings.The slightly whitish appearance remained on the surface of the catheter.Analysis of the returned guide did not detect a foreign material on the surface of the guide.Product analysis: pre-decontamination visual inspection: a slightly whitish appearance was observed on the surface of the catheter extending from the tip to 36.1cm from the end of the handle and 3.0cm from the distal end of the tip.There was no evidence of a residue on the surface of the catheter.Device decontaminated with cidex-opa pending further device testing to support the final product analysis findings.The slightly whitish appearance remained on the surface of the catheter.Analysis of the returned guide did not detect a foreign material on the surface of the guide.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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