Device evaluated by mfr: the device was returned for analysis.The advancer, handshake connections, sheath, and coil were microscopically and visually inspected.The sheath was noted to be split/torn 24cm distal of the strain relief.The split/torn shaft is consistent to damage caused by the hemostasis valve being over tightened.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
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