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As reported, when opening the device packaging, a hiwire nitinol hydrophilic wire guide was discovered to have no polymer jacket on a distal segment of the device, leaving only exposed nitinol wire.The device did not make patient contact, and there was no impact to the patient.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, when opening the device packaging, a hiwire nitinol hydrophilic wire guide was discovered to have no polymer jacket on a distal segment of the device, leaving only exposed nitinol wire.The device did not make patient contact, and there was no impact to the patient.Another of the same device was used to successfully complete the procedure.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection of the device were conducted during the investigation.One device was returned for investigation.8mm of the teflon jacket was missing from flexi-end of wire guide.The wire guide shows signs of scrapping/melting of material starting 3.5cm from the flexi-tip end of the device.The total length of scrapping/melting measured 2cm.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.The device was sent to the supplier for additional investigation.The supplier also conducted a review of their device history records.A review of the device history records of the device did not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The device presented a ductile/tensile overload fracture of the polymer jacket with material removal exposing the distal 0.70cm of the metallic core wire.The device also presented a large radius bend over the distal 5.15cm, consistent with tensile loading.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.The damage presented by the device appeared consistent with attempting to remove the specimen wire from the dispenser assembly without hydrating the wire as described in the device instructions for use.There were no identified gaps in the manufacturing instructions or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use provided with the device caution, ¿manipulation of wire guide requires appropriate imaging control.Use caution not to force or over manipulate the wire guide when gaining access.¿ the device ifu also provides thro following instructions for activating the hydrophilic coating: ¿the hydrophilic coating on the wire guide is activated by immersion in sterile water or sterile saline solution.1.Prior to using the wire guide, fill a syringe with sterile water or sterile saline solution and attach it to the flushing port on the wire guide.2.Inject enough solution to wet the wire guide surface entirely.This will activate the hydrophilic coating.¿ based on available evidence, cook has concluded that a definitive cause could not be established.It was noted that the failure is consistent with attempting to remove the wire guide without sufficient hydration.Cook will continue monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering 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 to a death or serious injury if a malfunction occurred.
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