Reportable based on analysis completed on (b)() 2014.It was reported that the device got kinked.The opticross imaging catheter was used to visualized 90% stenosed target lesion located in the moderately tortuous vessel.During percutaneous coronary intervention procedure, when introducing this device into a guide catheter the physician noticed that the device got kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition is good.However, returned device analysis revealed an open hole in the sheath at the lap joint assembly.
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Age at time of event: 18 years or older.Device evaluated by mfr: the complaint device was received with fluid was leaking from an open hole in the lap joint assembly when the catheter was flushed.No kinks were observed along the length of the catheter.The telescope assembly was not able to properly pull back, advance, or retract.During image characterization testing, no image appeared in the system due to electrical open at proximal.Based on the x-ray images, the electrical failure was a result of a broken coax cable.Imaging core wind up in the telescope 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 was unable to be determined.(b)(4).
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