It was reported that the patient presented with a st elevated myocardial infarction (stemi) and an occluded distal right coronary artery (rca).A prowaterflex guide wire crossed the distal rca lesion.A 2.5x15mm trek dilatation catheter was advanced to the lesion without resistance.Once at the lesion, the markers did not appear aligned co-axially aligned with the wire.After balloon inflation, the balloon locked with the wire and appeared deformed.The balloon was able to deflate, however it remained stuck and intertwined with the wire.Both were removed a single unit and the procedure was completed using another wire and balloon.There were no adverse patient effects and there was no clinically significant delay.The patient is in reported fine condition.There was no additional information provided.
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(b)(4).The device was returned for evaluation.The reported difficult to remove from the guide wire and unusual appearance was confirmed.The reported mis-aligned balloon markers were not confirmed due to the condition of the returned device.Based on visual, dimensional and analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to this complaint.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.The prowaterflex guide wire, referenced is being filed under a separate medwatch mfr number.
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