(b)(4).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.It was reported by the account that during inflation, the bdc was overinflated to 20 atmospheres (atms) and the balloon ruptured.It should be noted that the coronary dilatation catheters (cdc), nc trek, rx, global, instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek device is 18 atm; therefore, rbp was exceeded.It could not be determined if inflating the balloon slightly over the rated burst pressure contributed to the rupture.A conclusive cause for the reported difficulty removing the protective sheath could not be determined; however, the reported balloon rupture, difficulty advancing and removing the device from the anatomy appear to be related to 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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