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H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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As reported, during an "ep" procedure via access in the femoral artery, the tip of a micropuncture transitionless stiffened cannula access set's wire sheared off inside the patient.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information has been requested.Upon return and initial evaluation of the device, the wire was unraveled and separated.
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an "ep" procedure via access in the femoral artery, the tip of a micropuncture transitionless stiffened cannula access set's wire sheared off inside the patient.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Upon return and initial evaluation of the device, the wire was unraveled and separated.Additional information was received (b)(6), 2024.The access site was not scarred or calcified.Access was obtained using ultrasound guidance.Resistance was encountered upon insertion and/or removal of the device components.Per the physician, the wire would not pull out through the needle after it was advanced through the needle.The needle was removed, but the wire would not come out.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.Approximately 41.3-centimeters of the wire was elongated/unraveled, and the end was separated.A document-based investigation evaluation was performed.A review of the device history record found two relevant non-conformances on four total devices from subassembly lots; however, all affected product was scrapped.There were no relevant non-conformances on the final lot.A review of complaint history found no additional complaints for this lot number.The product ifu states ¿do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.¿ a review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.Although two relevant non-conformances were noted on sub-assembly lots, all non-conforming product was scrapped, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot-related complaints have been received from the field.Therefore, it was concluded that there is no evidence that additional non-conforming product exists in house or in the field.Based on the information provided and the results of the investigation, cook has concluded that a component failure, unrelated to manufacturing or design deficiencies, contributed to this event.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Additional information: b5.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Additional information was received 05feb2024.The access site was not scarred or calcified.Access was obtained using ultrasound guidance.Resistance was encountered upon insertion and/or removal of the device components.Per the physician, the wire would not pull out through the needle after it was advanced through the needle.The needle was removed, but the wire would not come out.
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