This report is being submitted as follow up no.1 to provide additional information in section b5, update section h3, and to provide the completed investigation results.One 119 cm 6fr r2p destination sheath and dilator were returned for product evaluation.Visual inspection of the sheath revealed that the tip of the sheath was broken off 0.59in from the sheath hub at the distal end of the strain relief.There were kinks noted along the sheath shaft at 3.14in, 6.5in, 18.9in, 21.4in, 24.5in, and 37.4in from the hub.No other anomalies were noted.Dimensional testing was performed.The sheath outer diameter (od) measured to be 0.0996in which was within the manufacturer's specifications.The sheath inner diameter (id) measured to be 0.086in which was within the manufacturer's specifications.The dilator was subjected to visual inspection and no anomalies were noted.The complaint can be confirmed for sheath mechanical separation.It is likely that pulling forces during withdrawal of the sheath in the presence of resistance likely caused the breakage.Per the product ifu: "while inserting or withdrawing, if resistance is met, do not advance or withdraw the sheath until the cause of resistance has been determined." the device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the fmea.
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