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Blank fields on this form indicate the information is unknown or unavailable.E1: customer phone = (b)(6).H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.Device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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, a 'hiwire nitinol hydrophilic wire guide' was found damaged when the package was opened prior to an unknown procedure.The device did not make patient contact.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.A preliminary device failure analysis of the complaint device was performed and scraping damage to the coating of the wire guide was noted, thus prompting this report.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.As reported, a 'hiwire nitinol hydrophilic wire guide' was found damaged when the package was opened prior to an unknown procedure.The device did not make patient contact.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.A preliminary device failure analysis of the complaint device was performed and scraping damage to the coating of the wire guide was noted, thus prompting this report.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control, as well as a visual inspection of the returned device, were conducted during the investigation.One hiwire nitinol hydrophilic wire guide was returned in an open package with label.The wire guide had been returned without protective tubing.No visible damage to the actual tip was observed, there is bend/curve in the wire.There is scraping damage to the jacket at approx.37cm from the distal tip.A document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A complaint history search did not identify any other complaints associated with the reported device lot.The evidence from the complaint file, device history record, complaint history and the supplier evaluation of the complaint device indicates that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house.The wire guide is assembled and packaged by a supplier to cook who carried out an investigation as well as cook.The nature of this damage is representative of attempting to remove the wire guide from the dispenser hoop without proper hydration.Please note that the product undergoes multiple inspections prior to product release.The condition of the returned specimen would not go undetected during these inspections.The supplier investigation was unable to confirm that the product did not meet specification prior to shipment.The investigation concluded that the product met specification at the time of shipment.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided and the evidence presented, it appeared that handling factors have contributed to the event as reported.Cook has concluded a cause for the complaint cannot be established it was not possible to rule out clinical / procedural factors.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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 toa death or serious injury if a malfunction occurred.
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