Reportable based on device analysis completed on (b)(4) 2014.It was reported that the shaft kinked.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified distal part of the right coronary artery.During a percutaneous coronary intervention, an opticross¿ imaging catheter was selected to view the target vessel.During the procedure, the inner catheter of the complaint device was repositioned after imaging the inner shaft became kinked.The procedure was competed with another of the same device.No patient complications were reported and the patient's condition is good.However, device analysis revealed a hole at the sheath lap joint section of the device.
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Age at time of event: 18 years or older.(b)(4).The complaint device was returned for evaluation.It was observed that the telescope assembly was able to properly pull back, advance, and retract.The distance from the distal end of the transducer housing to the tip of the catheter is within specification.During flushing, fluid was leaking at the sheath lap joint junction between the blue sheath and clear imaging window tubing.The hole was on the outside section of the bond junction.During image characterization testing, no image appeared in the system due to electrical open at proximal.Imaging core windup was found in the telescope assembly.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 was unable to be determined.(b)(4).
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