(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.The reported patient effects of death and perforation are listed in the coronary dilatation catheters, nc trek rx, instruction for use, as known patient effects.A review of the lot history record could not be conducted because the lot number was not provided.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.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 that the procedure was performed to treat a lesion in the left anterior descending artery.During preparation of the artery a non-abbott atherectomy system was used and followed by pre-dilatation with a 3.0x20mm nc trek balloon dilatation catheter; however, a perforation was noted.The perforation caused a pericardial effusion which resulted in cardiac tamponade.Pericardiocentesis was performed; however, the patient expired.No additional information was provided.
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