Reportable based on device analysis completed on (b)(4) 2014.It was reported that resistance and lost image occured.During percutaneous coronary intervention (pci), an opticross imaging catheter was used to view the lesion.After using the opticross, resistance was encountered when getting back the telescope on its initial position and then lost image was noted.The procedure was completed with different device.No patient complications were reported and the patient's status was good.However, device analysis revealed a hole at the lap joint area of the catheter.
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Device evaluated by manufacturer: the complaint device was returned for analysis.Evaluation of the returned device revealed that the telescope assembly was not able to properly pull back, advance, and retract.Since the telescope cannot advance the transducer distal housing (tdh) to the most distal position, the distance from the distal end of the transducer housing to the tip of the catheter was not measured.Fluid was leaking from an open hole at the lap joint area when the catheter was flushed.The imaging window is still connected to the blue sheath at the lap joint.Fluid was leaking from an open hole at the lap joint area when the catheter was flushed.The imaging window is still connected to the blue sheath at the lap joint.During image characterization testing, no image appeared in the system due to electrical open at proximal.The complaint device was sent for x-ray analysis to further characterize the electrical failure.Based on the x-ray images, the electrical failure was a result of a broken coax cable.Imaging core wind up in the hub assembly was observed during x-ray analysis.No other issues or defects were observed during product analysis of the returned device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
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