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Blank fields on this form indicate the information is previously submitted, unknown, or unavailable investigation ¿ evaluation.A review of the complaint history, device history record, documentation, drawing, manufacturing instructions, quality control data, specifications, and visual inspection/ dimensional verification of the device was conducted during the investigation.Clinical assessment: the customer states, ¿the tip of the guide could no longer retract from the needle.¿ it is feasible to suggest the attempt to retract the wire through the needle contributed to the wire guide separation.Therefore, the probable cause of this event is user technique related.Two needle cannulas, a stiffening cannula, a trocar, and a wire guide were returned in a used condition.1 needle cannula and the stiffening cannula both contained a trocar in the lumen.The distal portion of the wire guide was unraveled with both the proximal and distal welds of the guide being found intact.The mandril diameter and the inner diameter of the needle cannula were both measured within specifications.It is likely that the wire guide became unraveled during removal from the needle cannula.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.Additionally, a search of the manufacturer's complaint database revealed no additional complaints have been reported for lot 8133562.Based on this information, the root cause of this complaint is likely use technique.It was stated that the customer could not retract the guide through the needle, which goes against the warning affixed to the wire guide holder stating that damage may occur if the wire guide is withdrawn through a needle.Investigation results letter to be sent to representative and customer.We will notify appropriate personnel and will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.Blank fields on this form indicate the information is previously submitted, unknown, or unavailable investigation ¿ evaluation a review of the complaint history, device history record, documentation, drawing, manufacturing instructions, quality control data, specifications, and visual inspection/ dimensional verification of the device was conducted during the investigation.Clinical assessment: the customer states, ¿the tip of the guide could no longer retract from the needle.¿ it is feasible to suggest the attempt to retract the wire through the needle contributed to the wire guide separation.Therefore, the probable cause of this event is user technique related.Two needle cannulas, a stiffening cannula, a trocar, and a wire guide were returned in a used condition.1 needle cannula and the stiffening cannula both contained a trocar in the lumen.The distal portion of the wire guide was unraveled with both the proximal and distal welds of the guide being found intact.The mandril diameter and the inner diameter of the needle cannula were both measured within specifications.It is likely that the wire guide became unraveled during removal from the needle cannula.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.Additionally, a search of the manufacturer's complaint database revealed no additional complaints have been reported for lot 8133562.Based on this information, the root cause of this complaint is likely use technique.It was stated that the customer could not retract the guide through the needle, which goes against the warning affixed to the wire guide holder stating that damage may occur if the wire guide is withdrawn through a needle.Investigation results letter to be sent to representative and customer.We will notify appropriate personnel and will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Medtronic received a report that a patient experienced vascular damage including perforation following a procedure involving a pipeline, phenom catheter, and navien catheter.The patient was undergoing treatment for an unruptured aneurysm located in the c6 segment of the left internal carotid artery.The height was 13.7mm, the max diameter was 25.0mm, the dome diameter was 25.0mm, and the neck diameter was 9.2mm. it was reported that the pipeline was successfully placed.It was noted that a balloon catheter was used for angioplasty, but there were no malfunctions with the devices.The patient also experienced vessel spasm.It was noted that it was difficult to perform the surgery based on the patient's general condition.They were treated fasudil hydrochloride iv drip and intraarterial injection and the event led to extended hospitalization.The adverse event was assessed as not related to the devices, but could not be ruled out as potentially related to the procedure.The patient recovered on (b)(6) 2021 and had an mrs score of 0.
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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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