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, trend 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 was confirmed; however, the root cause was not identified.The product returned for evaluation was one straight guidewire.The sample was received in its plastic hoop.No obvious usage residues were observed.Following removal of the wire from its hoop, a kink was observed 1.7cm from the distal tip.Both weld tips were intact.A bend was also observed in the wire just proximal of the kink.Microscopic inspection of the wire confirmed misalignment of the outer coils at the kink site.An additional site of coil misalignment was observed just distal of the primary kink.No usage residues were observed during microscopic inspection of the sample.The bend and kinks in the guidewire appeared consistent with device manipulation; however, it could not be determined when/how such manipulation occurred.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.A lot history review (lhr) of rebr0856 showed no other similar product complaint(s) from this lot number.
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