|
As reported, during an upper extremity angio of the left arm and using a roadrunner extra-support bare mandril wire guide, the tip of the wire unraveled.Access was gained through the right femoral artery.The patient's anatomy was noted to be very calcified and could be seen under fluoro.No kinking of the wire was noted.The distal end of the tip of the wire unraveled when they were attempting to reintroduce the device into the patient.The wire unraveled outside of the patient.It was noted that it had not been removed through a needle or another wire, but only through catheters that were used to exchange other wires.They decided not to re-use the wire and successfully completed the procedure using another device of the same type but a different lot.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.
|
|
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary as reported, during an upper extremity angiography of the left arm and using a roadrunner extra-support bare mandril wire guide, the tip of the wire unraveled.Access was gained through the right femoral artery.The patient's anatomy was noted to be very calcified and could be seen under fluoroscopy.No kinking of the wire was noted.The distal end of the tip of the wire unraveled when they were attempting to reintroduce the device into the patient.The wire unraveled outside of the patient.It was noted that it had not been removed through a needle or another wire, but only through catheters that were used to exchange other wires.They decided not to re-use the wire and successfully completed the procedure using another device of the same type but a different lot.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.Investigation - evaluation: reviews of 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 used and damaged roadrunner extra-support bare mandril wire guide (rstf-14-300) was returned to cook for investigation.Visual examination confirmed the solder connection was broken away from inner mandril wire (distal tip) resulting in coil elongation.The solder connection at distal tip was intact.A document-based investigation evaluation was also performed.One relevant nonconformance was recorded; all affected devices were scrapped.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 state the following: ¿ withdraw wire guide under fluoroscopy slowly and gently to prevent trauma.Note: after removing wire guide from catheter, wipe with sterile gauze pad moistened with heparinized saline solution or sterile water and place back into holder.Close hemostatic valve, flush line, and prepare a new wire guide.Warning: prior to re-inserting exchanged wire guide, verify that distal tip of cardiovascular device is free within vessel.¿ based on the available information, cook has concluded that the patient¿s severely calcified anatomy contributed to the device failure.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.
|
