The supplier provided their evaluation of the issue: a device history record review was performed.The review of the lot record documentation indicated that the product was manufactured according to the established processes and procedures.There were no related non-conformances or deviations noted on the specified lots, and the associated operators were trained to the most recent document revisions based on the date of manufacture.A tip is over molded onto the stainless steel tip by the supplier, and there was no damage to the mold indicating that the wire had been correctly loaded into the tool.Six samples were tested in an attempt to recreate the separated tip issue using hand pressure.Hand pressure was placed on the tips at various angles while holding the tipped end of the guidewire.This technique was used to place as much force on the machined tip in an attempt to separate.No tips separated during the testing.Another attempt was made to separate the tip by pushing the tip against a flat hard surface (table surface).The machined tip did bend at the base of the tip, but the tip did not separate during this test.A definitive root cause of the separated tip could not be determined.The investigation of the molding and assembly process could not reproduce the issue observed.
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