(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Dilatation catheter: lacrosse; guide wire: sion; guide catheter: heartrail.Evaluation summary: the device was returned for analysis.The reported material rupture was not confirmed, as the balloon was inflated and held pressure with no anomalies noted.The difficulty to position could not be tested due to the condition of the returned device.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 similar incidents from this lot.The investigation determined the reported difficulty to position appears to be related to circumstances of the procedure.The investigation was unable to determine a conclusive cause for the reported material rupture as no rupture was noted during return device analysis.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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It was reported that during a procedure of the non-tortuous, eccentric, mildly calcified, 80% stenosed, de novo bifurcation of the left main (lm) and proximal left anterior descending artery (lad), after pre-dilatation, the 3.0 x 18 mm xience sierra stent was implanted at 16 atmosphere (atm) and post-dilatated with the stent delivery balloon.The stent delivery system (sds) was removed from the anatomy.A 2.5 x 10 mm non-abbott balloon dilatation catheter (bdc) was advanced over the stent struts and dilated in the lmt and circumflex (cx).The xience sierra sds was re-inserted and used for kissing balloon technique (kbt); however, resistance was met in the guide catheter which was located at the aortic arch.During kbt inflation, the sds balloon ruptured at 14 atm.The device was removed and an unspecified high pressure balloon was used to complete the procedure.There was no reported adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.
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