The product was not returned to abbott vascular for analysis.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 and/or complaints reported from this lot.In this case, the device was prepped prior to use and inflated twice prior to the rupture with no issue/ leak noted, which would suggest that a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure.Based on the reported information, in this case, it is likely that after multiple inflations and/or repositioning, the balloon became compromised and/or damaged against the anatomy resulting in the reported balloon rupture during the third inflation at 10 atmospheres.The balloon rupture likely caused the inner member to lock the guide wire in place resulting in the difficulty to remove the guide wire.Additionally, the treatment appears to be related to the operational context of the procedure as the sheath was upsized to a 7fr sheath and both devices were able to be pulled out together.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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