It was reported that the procedure was to treat a lesion in both the anterior descending branch and the diagonal branch.The hi-torque (ht) turntrac guide wire reached the distal end of the diagonal branch without resistance while a non-abbott guide wire reached the anterior descending branch.However, after the lesions were treated, it appeared that the guide wire was under the stent and the physician used a small balloon to try to retrieve the guide wire of the pulling wire but broke.Force was applied during attempt at removal.Under intravascular ultrasound, it was found that the guide wire had the possibility of being in the stent, and finally decided to place an additional stent to compress the guide wire and finally completed the operation.There was no adverse patient sequelae and there was no clinically significant delay in the procedure.No additional information was provided.
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A visual inspection was performed on the returned device.The reported material separation was confirmed.The reported entrapment of device and device damaged by another device could not be tested as they are based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.It was reported that the force was applied to the guide wire during removal when resistance was encountered.It should be noted that the hi-torque turntrac guide wire instructions for use (ifu) states: do not: ¿push, auger, withdraw, or torque a guide wire that meets resistance.If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.¿ in this case, it was reported that the force used during removal of the guide wire was due to interaction with an implanted stent.For this reason, the force applied appears to be a reasonable clinical response to the difficulties.It was reported that guide wire became entrapped with the stent post implantation.It should be noted that the hi-torque turntrac guide wire instructions for use (ifu) states: do not: ¿deploy a stent such that it will entrap the wire between the vessel wall and the stent.¿ the investigation determined the reported difficulties appear to be related to the user error.The reported treatments appear to be related to operational circumstances of the procedure.An additional stent was implanted to secure the separated wire in the vessel.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.
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