It was reported that the procedure was to treat a de novo, 90% stenosed, heavily calcified and mildly tortuous vessel in the right coronary artery (rca).Prior to use, the 3.0x15mm trek rx balloon dilatation catheter (bdc) was soaked in saline and was prepped (air aspiration) outside the anatomy.There was no resistance when the protective sheath was removed.The bdc had resistance with the anatomy during advancement and ruptured at a pressure of 8 atmospheres (atms) on the first inflation.There was no resistance during removal.A non-abbott balloon was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
|
The device was not returned for evaluation.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 similar incidents and/or complaints from this lot.The investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
|