(b)(4).Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter in two pieces.The shaft and hypotube were microscopically and visually examined.There was contrast in the inflation lumen and blood in the guidewire lumen.Although it was reported that the device was not used, the presence of blood in the guidewire lumen and contrast media in the inflation lumen is indicative of handling beyond simply unpackaging the device, as was reported.The balloon was tightly folded.There was a complete hypotube separation 73 cm from the strain relief and numerous hypotube kinks.The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.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 26may2017.It was reported that shaft kink occurred.A 3.5mm x 12mm quantum¿ maverick¿ balloon catheter was selected for use.During unpacking, it was noted that the delivery shaft was kinked.The device never went inside the patient's body and 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 a hypotube break.
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