As reported to customer relations via complaint form "we have had many wires break off when pulling them out over the past few months.We typically pull the wires on pod5-7 and did not have issues but recently, they are extremely hard to pull out and break off proximal to the doppler itself.This led to a practice change that the wire would be cut with a tail external to the patient and pulled out two weeks later in clinic.The hospital required another practice change as they considered that a retained foreign body.Therefore, my partner pulled this one and again, had significant resistance and the wire broke.This caused an arterial injury on an otherwise viable flap on pod 5-7.The flap ultimately required revision twice and has now failed.There is no doubt it was related to the trauma caused by the wire.".
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.No device was returned to cvi, therefore a physical investigation of the device could not be performed.The complaint could not be confirmed through a physical investigation.Per ifu (d00078672 rev003): "the cook-swartz doppler flow probe should only be used with the cook doppler blood flow monitor.", "avoid use of excessive force to remove the transducer assembly from the patient, which may cause injury to the blood vessel.If the transducer assembly can not be removed using gentle traction, the transducer assembly should be removed surgically.", "changes in audio signals produced by the cook doppler blood flow monitor system should be immediately documented and reported to the responsible healthcare provider.", "caution: do not remove the probe conductor wire and crystal assembly (leaving only the cuff in situ on the vessel), until vessel monitoring is completed (commonly 3-5 days).Probe conductor wire and crystal assembly placement must not exceed 29 days.Cuff alone may remain within the patient indefinitely.", "avoid the application of electrosurgical energy on or near a connected cook-swartz doppler flow probe or extension cable as damage to the monitor may occur.", "use of the cook-swartz doppler flow probe involves potential risks normally associated with any implanted device, e.G., infection, perforation or laceration of vessels, erosion, implant rejection, or device dislodgement/migration.", "device specific risks include separation of the doppler crystal from the cuff, inability to percutaneously remove the crystal after monitoring is complete, loss of reception or transmission of ultrasound monitoring signal." this report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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