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As reported, while using a bander ureteral diversion stent set during a stent placement procedure, the guide wire broke off inside of the stent while the surgeon was attempting to remove the guide wire.No other devices were used with the guide wire prior to the stent, and there was a lot of resistance noted when removing the guide wire.The stent was removed from the patient, and no section of the device was left inside of the patient.A new stent was used to complete the procedure.No unintended part of the device remained inside the patient's body.No additional procedure was required due to this occurrence.No adverse effect on the patient was reported due to this occurrence.
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Event summary: as reported, while using a bander ureteral diversion stent set during a stent placement procedure, the guide wire broke off inside of the stent while the surgeon was attempting to remove the guide wire.No other devices were used with the guide wire prior to the stent, and there was a lot of resistance noted when removing the guide wire.The stent was removed from the patient, and no section of the device was left inside of the patient.A new stent was used to complete the procedure.No unintended part of the device remained inside the patient's body.No additional procedure was required due to this occurrence.No adverse effect on the patient was reported due to this occurrence.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, and quality control procedures and a visual inspection of the device were conducted during the investigation.The wire guide was returned in open packaging labelled with lot 14090673 and partially inserted into the stent.The wire guide was removed from stent with no resistance.The green external coil was unwound from the middle of the wire guide for approximately 26.5cm, revealing the inner wire.No external cause of damage was apparent.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.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which provide the following information related to the reported failure mode: -manipulation of the wire guide required appropriate imaging control.Use caution not to force or over manipulate the wire guide when gaining access.-when using a wire guide through a metal cannula/needle, use caution as damage may occur to outer coating.-hydrophilically coated wires are very slippery when wet.Always maintain control of the wire guide when manipulating it through any device.Based on the available information, cook has concluded that a cause for this event could not be determined.Cook will continue monitoring of similar complaints and has 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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