As originally reported, during an unknown procedure, a roadrunner uniglide hydrophilic wire guide was "sticky and tacky", even when kept wet in a basin of sterile water when not in use.The wire was attempted to be advanced through a cook catheter, however, resistance was felt and the wire became "impossible to pass".Upon removal of the wire, the user was concerned that the coating would "shear off"; however, there was no report any shearing/separation of the coating.Per the reporter, the "sticky and tacky" feeling was felt with any device tracked over this wire.The wire was removed, and a competitor's wire was used for the procedure.A section of the device did not remain inside the patient's body.The patient did not experience any adverse effects or require any additional procedures due to the occurrence.Additional information was received 11mar2024, stating that "clear gelatinous and sometimes powdery" material flaked from the wire; however, the metal was not exposed.Both latex and powdered gloves were worn, and the coating was initially activated with heparinized saline.The wire was used immediately after activation and was used one time.
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Summary of event: as originally reported, during an unknown procedure, a roadrunner uniglide hydrophilic wire guide was "sticky and tacky", even when kept wet in a basin of sterile water when not in use.The wire was attempted to be advanced through a cook catheter; however, resistance was felt, and the wire became "impossible to pass".Upon removal of the wire, the user was concerned that the coating would "shear off"; however, there was no report any shearing/separation of the coating.Per the reporter, the "sticky and tacky" feeling was felt with any device tracked over this wire.The wire was removed, and a competitor's wire was used for the procedure.A section of the device did not remain inside the patient's body.The patient did not experience any adverse effects or require any additional procedures due to the occurrence.Additional information was received (b)(6) 2024, stating that "clear gelatinous and sometimes powdery" material flaked from the wire; however, the metal was not exposed.Both latex and powdered gloves were worn, and the coating was initially activated with heparinized saline.The wire was used immediately after activation and was used one time.Investigation evaluation: reviews of the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions, specifications, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.One additional complaint from the field for the same failure mode as the complaint device was found.The component lots associated with the complaint lot record no relevant non-conformances.There were no non-conformances relevant to the reported failure mode, and no other lot related complaints have been received from the field.At this time, cook has concluded that no non-conforming product from this lot exists in house or in the field.The product ifu was reviewed, and the customer followed all relevant instructions in the ifu related to this failure.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 complaint file suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.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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