(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The incident information was reviewed; however, the product was not returned to abbott vascular for analysis.It should be noted that armada 35 instructions for use (ifu), states: inflation in excess of the rated burst pressure (rbp) may cause the balloon to rupture.Use of a pressure monitoring device is recommended.In this case, the physician pressurized the balloon above the rbp of 10 atmospheres multiple times, which resulted in the balloon rupture.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 reported from this lot.The investigation determined the reported balloon rupture appears to be related to the user error as the balloon was inflated above rbp.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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