Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr.Returned device consisted of a coyote es balloon catheter with blood in the balloon and inflation lumen.The balloon, markerbands, tip, shaft and proximal weld were microscopically inspected.Inspection revealed a pinhole in the balloon material, located over the distal edge of the markerband.Inspection also found damage to the tip and kinks in the shaft 3cm and 66.5cm from the tip of the device.Microscopic inspection found the remainder of the device free of damage.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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