Age at time of event: 18 years or older.Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 47.8cm distal of the strain relief.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported kink.
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Reportable based on device analysis completed on 16 may 2020.It was reported that shaft kink occurred.A 2.5mm x 12mm quantum maverick balloon catheter was selected for use.However, during unpacking, it was noted that the shaft was kinked.However, returned device analysis revealed shaft detached/ separated.
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