It was reported that the procedure was performed to treat a lesion in the 60% stenosed lesion in the middle third right coronary artery and circumflex artery.The ht bmw universal ii guide wire was positioned; however, the balloon catheter could not be progressed and resistance between the devices was felt during advancement.When removing the entire assembly, it was noticed that the guide wire tip polymer was peeled.No polymer was left in the patient.The procedure was successfully completed with a non-abbott device.No additional information was provided.
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The device was not returned for analysis.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 of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported difficulties.Factors that may contribute to difficulty advancing the balloon catheter over the guide wire include, but are not limited to, inner diameter of the catheter, outer diameter of the guide wire, device support, buildup of procedural contaminants, user technique, and/or damage to the catheter or guide wire.In this case, based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported difficult to advance.Additionally, the reported peeled/delaminated tip was noted after removal from the anatomy.It is possible that manipulation of the guide wire when resistance with the catheter was encountered, resulted in the reported peeled / delaminated tip; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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