Received response: Investigation summary

Liva Nova received a report stating that, during the procedure, the tip of the SU-29602 cannula came off. No defects were noted before starting the procedure, however the cannula detached during use but having recovered it immediately, no patient was affected.

A photo was provided as evidence of the defect, in particular the disconnected part was between: spring, inner tubing (PN 20742)and connector (PN 20741). The DHR review highlighted that the lot whose claimed product belong to was released as conform according to specifications. Up until April 2022, other similar complaints were recorded from different customers but on different cannula lots. The factors that could contribute to the reported issues are: (i) a failure during the manufacturing steps to apply the proximal connector on the tip assembly, performed by the operators, so that an adequate bonding was not guaranteed and / or (ii) a defective supplier component due to out of specs. The unit has been requested for investigation, and received in Arvada. Per MOP 6003-032, the connection site between the connector and the tubing should have a feature that did not appear to be present on returned unit, the seam between the tubing and the connector should have a visible bead of extra UV adhesive. While there is a thin layer of adhesive, it would appearthat this layer is flat and would hardly provide additional support to thisconnection. Moreover, the critical dimensions for this connection site were evaluated and the results revealed that the components used in this assembly appear to have been in specification. Therefore, no supplier issue occurred. Based on all facts mentioned, it cannot be ruled out that the root cause of th etip detachment is related to a manufacturing deviation during the assembly phase. The issue was addressed within CAPA-ARV-2022-0005. Further corrective action will be implemented through the CAPA process. Liva Nova maintains and document periodic customer events monitoring process in order to evaluate actions for products improvement.