(b)(4 internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Incorrect anatomy.Evaluation summary: visual inspection was performed on the returned device.The shaft separation was confirmed.It should be noted that the information for use, states: the trek rx coronary dilatation catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion, balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction and balloon dilatation of a stent after implantation.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.The investigation was unable to determine a conclusive cause for the reported complaint as limited information of the original procedure was reported; however, the reported patient effects of dyspnea, foreign body in patient, additional treatment and hospitalization appear to be related to the reported separation or circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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It was reported the patient had a procedure performed on (b)(6) to treat a lesion in a pulmonary vessel with a 3.5 x 30 mm rx trek balloon catheter.The procedure was completed successfully with no consequences noted.However, five months later (b)(6), the patient experienced dyspnea.Time-division multiplexing (tdm) imaging [fluoroscopy] was performed and it was observed that the distal part of the trek balloon catheter had separated and was left in the pulmonary artery at the time of procedure on (b)(6).The separated distal section of the device was retrieved successfully with a lasso technique and no surgery was required.After, the patients condition was fine and no treatment was needed for the dyspnea.No additional information was provided.
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