The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other similar complaints.Balloon material ruptures can be affected by numerous factors including, but not limited to, balloon damage during processing of the balloon material, materials, inflation technique, and interactions with other devices, lesion calcification, or insufficient preparation prior to use.Based on the information provided, the reported balloon rupture was likely due to circumstances of the procedure.It is likely that the balloon rupture was the result of interaction with the previously placed non-abbott stent which was reported to be fractured.Additionally, the difficulty removing, and separation occurred due to the ruptured balloon material catching on the fractured stent strut that was sticking out.The additional treatment to snare and remove the separated portion of the balloon was related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported the procedure was performed to treat a heavily calcified lesion in the left common iliac artery.The 8.0mm x 40mm x 80 cm armada balloon dilatation catheter (bdc) was to post dilate a previously implanted non-abbott stent.The previously implanted stent was fractured and one of the stent struts was sticking out.The armada balloon was advanced; however, during the first inflation at 8 atmospheres, the stent strut ruptured the balloon.The bdc was removed, but the balloon was caught on the stent strut, resulting in a portion of the balloon separating and remaining in the patient.The separated segment was successfully snared and removed, so no portion remained in the anatomy.There was no adverse patient effect or a clinically significant delay in the procedure.An omnilink stent was successfully implanted and post dilated to complete the procedure.No additional information was provided.
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