(b)(4).The device was not returned 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 similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties removing the device from the dispenser coil, deflation issues, or leak.The difficulties removing the device from the anatomy appear to be related to circumstances of the procedure as it is likely that an interaction of the partially deflated balloon with the anatomy caused the resistance.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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