(b)(4).Device evaluated by manufacturer: the device was returned for analysis.The hypotube, collar and tip were microscopically and tactilely inspected.Inspection revealed a kink in the hypotube located 71 cm from the strain relief, numerous kinks in the distal shaft, and collar damage (slight lifting of shaft material from collar/chatter lines).Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
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Reportable based on device analysis completed on 30-apr-2018.It was reported that burr was unable to advance within the catheter.A guidezilla¿ ii guide extension catheter was selected for use.During the procedure, it was noted that the rotalink burr would not enter into the guidezilla.The device was removed from the patient's body.The procedure was completed with another device.No patient complications were reported and patient's status was okay.However, device analysis revealed a slight lifting of shaft material from collar/chatter lines.
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