(b)(4).Device evaluated by mfr: returned device consisted of a coyote es balloon catheter hub, strain relief hypotube and part of the distal shaft.The distal tip and most of the distal shaft was not returned for analysis.Detachment of the shaft occurred inside the patient.The detached part of the device was captured with snare and removed outside the body.Missing part had been disposed of at user facility.The hypotube and distal shaft were microscopically and tactile inspected.Inspection revealed numerous kinks in the hypotube, and only 9 cm of the distal shaft was attached to the device.Further inspection revealed that the distal shaft showed signs of excessive tension, resulting in a shaft separation and numerous kinks.The hypotube fractured near the end of the separated distal shaft, with the end of the hypotube oval in shape, appearing as if kinked just prior to separation.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported crossing difficulty, which could not be confirmed because the clinical circumstances could not be replicated.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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