An end user reported an issue with a pvak -- 400 micron perforator and accessory vein ablation kit.During a procedure, the fiber broke (complete detachment) just above the compression clamp.The procedure was completed with another same device and the issue occurred outside of the patient; therefore, the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.The fiber was inspected prior to use and did not show any signs of a defect.
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The customer's reported complaint description of "fiber was fractured and detached" was confirmed via picture provided by the customer; however, no sample was returned.Without receiving a sample for evaluation, the root cause could not be determined.Manufacturing personnel 100% visually inspect devices during the packaging process.This type of fiber kink/detached damage would be noticed prior to shipment.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 instructions for use (14601411-01), which is supplied to the end user with this catalog number, states: "prior to and during use, avoid damaging the fiber by striking, stressing, or excessive bending.Do not coil the fiber tighter than a diameter of 20cm.Clinical safety and effectiveness data is not available for other fiber tip designs and diameters.Prior to and during use, avoid bending the introducer sheath and dilator as this can cause kinks and damage".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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