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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
|
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 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 ¿pretzeled¿ guidewire was confirmed and appeared to have occurred during use.The product returned for evaluation was a 0.018" x 50cm nitinol guidewire.The sample contained blood-like residue throughout indicating use.A tight knot in the guidewire was seen at the proximal end of the wire, within the "j" tip.Blood and tissue-like residue was seen within the knot.Microscopic examination of the sample was unremarkable.The weld tip was intact and no potential manufacture causes or contributing factors were observed.This type of failure can possibly occur as an anomaly of guidewire movement through a tortuous path.In order for a knot to form there would need to be forward motion against an obstacle, a twisting motion in order to bring the wire through the potential loop, and a backward motion (such as withdrawal of the wire).Avoiding twisting motions (particularly when encountering insertion difficulty) may help to avoid the alleged event.No evidence of a manufacture deficiency was observed during the investigation.
|