Device evaluation by mfr.: unit returned with its original box and together with a non-bsc catheter, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The guidewire returned together with its original opened pouch; besides, a non-bsc device was received.The device has the body kinked approximately at 7.5 cm, 49 cm, 77.5 cm and 123 cm from the proximal end.The guidewire distal tip was bent.The polymer distal tip was damaged.No more damages were found in the device.During the inspection, it was noted that the proximal end of the polymer tip was folded on itself; the folded section measured approximately 0.4 cm.The overall length of the device is within specification.The outer diameter of the distal tip, middle of the device, and proximal section are within specification.
|
Reportable based on device analysis completed on 07may2020.It was reported that inserting difficulties were encountered.The 99% stenosed target lesion was located in the severely tortuous and mildly calcified forearm shunt.A 150cm, 8cm poly tip v-18 control wire guidewire was selected for use in combination with a non-bsc balloon catheter.However, the guidewire had difficulty inserting into the guidewire lumen of the balloon catheter.Both devices were removed and the procedure was completed with another of same device.No patient complications nor injuries were reported.However, returned device analysis revealed guidewire coating peeled/sheared.
|