While prepping the fiber for the case, the a pvak -- 400 micron perforator fiber bent/fractured and almost snapped.A new fiber was used to complete the procedure.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.
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As the reported device was not returned, angiodynamics is unable to perform a device evaluation.However, the customer did provide a picture showing the fiber fractured (picture was not very clear).The customer's reported complaint of fiber fractured/broken was confirmed via picture provided, however, without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.At the vendor facility, during the manufacturing process, fibers are repeatedly bent and coiled and there is a final visual inspection performed with a hene laser to check the entire fiber length for defects prior to shipment.During the packaging step, the fibers are inspected for damage.It is unlikely that the fiber was fractured prior to packaging.The most likely root cause to this event is due to handling after the device left the angiodynamics facility.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the directions for use which is supplied to the end user with the reported catalog number contains the following statement "prior to and during use, avoid damaging the fiber by striking, stressing or excessive bending.Do not coil the fiber tighter than a radius of 60mm".A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).
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