Reportable based on the investigation completed on (b)(4) 2015.It was reported that a resistance was encountered.During the procedure, a 1.75 mm rotalink¿ plus was selected to treat the unspecified target lesion.Upon delivering the device into an unspecified guidewire, it was then noted that the device could not be advanced smoothly as resistance was encountered.The guidewire was checked, however, no issues were noted.The procedure was then completed using another of the same device.No patient complications were reported and the patient's status is good.However, device analysis revealed of a saline leakage through a pin hole in the strain relief.
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(b)(4).Device evaluated by manufacturer: device was returned for analysis.A visual examination of the complaint unit was carried out and no issues were noted.The handshake connection was inspected and no damage was noted.The drive shaft, coil and sheath were inspected and there was no damage noted.An attempt was made to load a test guidewire though the device but it would not load through the burr of the catheter.The burr was microscopically examined and revealed that the annulus of the burr was found to be misshapen and damaged.An attempt was made to wet test and revealed that the device leaked from under the strain relief.The strain relief was removed and a pin hole was evident.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
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