(b)(4).(b)(6).(b)(4).Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter in two pieces.The balloon was tightly folded.The hypotube and inner/outer shaft was microscopically examined.The hypotube broke/fractured 73cm from the strain relief with a kink at 71cm from the strain relief.The fracture faces were oval as if kinked prior to separation.There was no evidence of any material or manufacturing deficiencies contributing to the damage.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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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Reportable based on analysis completed on 22-jul-2016.It was reported that shaft kink occurred.The 75% stenosed, 13mm in length, 1.3mm in diameter target lesion was located in the severely tortuous and moderately calcified left anterior descending artery.A 1.50mmx15mm maverick balloon catheter was advanced to the lesion.However, during procedure, it was noted that the shaft was kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed hypotube break.
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