When the doctor went to place the fiber, from a pvak -- 400 micron fiber procedure kit,.The fiber fractured outside the patient.No part of the fiber had been inserted in the patient at that time.The procedure was completed with a new of the same device.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 end user provided a photo showing the shaft was fractured and detached.The customer's reported complaint description of fiber was fractured and detached was confirmed based on picture provided by the customer.Although the complaint description is confirmed, without a sample for evaluation a definitive root cause cannot be determined.Potential root cause for this type of failure mode is handling damage after leaving the angiodynamics manufacturing facility; i.E.During transit/shipping and/or storage and procedure preparation.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.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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