The product was returned with the membrane completely unfolded with blood on the exterior and interior of the catheter.A maquet sheath, pressure tubing, extender tubing and a 0.025¿ guidewire was also returned.The sheath was slightly ribbed near the hub and the guidewire was still within the device, both kinked and unraveled at approximately 94cm & 134.6cm from the non-j-tip end respectively.An inner lumen break within a kink was observed within the membrane at approximately 27.4cm from the iab tip.Additionally, two catheter tubing kinks were also observed near the y-fitting at approximately 76.5cm & 77cm from the iab tip.The evaluation confirms the presence of a kink as an as analyzed failure.However, we are unable to conclusively determine when this kink may have occurred.Therefore, the root cause for the kink is impossible to define.A device and lot history record review was completed for the reported product.No non conformance's were found that are considered to be related to the event.The initial reporter named is a getinge employee whose contact details are: (b)(6) / phone number: (b)(6) / e-mail address: (b)(6); which differs from that of the event site.Complaint #: (b)(4).
|