The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebr0386 showed one other similar product complaint(s) from this lot number.Both complaints for this lot number (rebr0386) have been reported from the same facility.
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The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire is confirmed; however the root cause is unknown.One 135 cm nitinol guidewire was returned for evaluation.The core wire appeared to be broken during tactile evaluation.A microscopic observation revealed the outer coiled wire was slightly unraveled for the majority of the flexible, gold section at the distal end of the guidewire.The core wire was observed to indeed be broken about 7 cm proximal to the weld tip, which was observed to be intact and undamaged.Some whitish residue was observed on the outer coiled wire of the guidewire and a kink was observed about 4.5 cm proximal to the weld tip.The core wire of the guidewire was observed to be tapered near the fracture site and had a granular fracture surface, which is typical of a tensile failure.The distal end of the guidewire was unraveled further in order to locate and observed the distal fracture surface of the core wire.The distal fracture surface of the core wire was also observed to be granular in texture.While the exact cause of the tensile break in the core wire of the guidewire could not be determined, possible contributing factors include failure to hydrate the guidewire prior to removing it from the hoop, excess force during removal of the guidewire from the hoop, and advancement/retraction of the guidewire against resistance.A lot history review (lhr) of rebr0386 showed one other similar product complaint(s) from this lot number.Both complaints for this lot number (rebr0386) have been reported from the same facility.
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