The device was returned for analysis.The reported deformation due to compressive stress was confirmed.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 from this lot.The investigation was unable to determine a conclusive cause for the reported deformation due to compressive stress; however, factors that could contribute to shaft kink (deformation due to compressive stress) includes, but are not limited to, manufacturing damage, damaged during shipping, and product damage during handling by user during dispenser removal.Additionally, holes were found in both the inner and outer member consistent with guidewire and/or stylet damage.The noted damage was near the confirmed kink (deformation due to compressive stress).The account was contacted to inquire about the returned device condition; however, the physician indicated that he no longer could remember details about the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience pro a device is currently not commercially available in the us; however, it is similar to a device sold in the us.
|