H10: manufacturing review: a complaint history review was performed.This is the eleventh complaint reported for this lot number and the lot met all release criteria.A device history record review is required.Investigation summary: one guide-wire in a guide-wire hoop was returned for evaluation.Visual, microscopic, tactual, functional, and dimensional evaluations were performed.Sample appeared to have residue.The investigation can be confirmed for the identified fracture and stretching issues as the inner wire was found to be fractured and the guidewire was stretched near the point of unraveling.However, the investigation is inconclusive for the reported failure to advance issue as exact circumstances at the time of the reported event are unknown.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: section a through f - the information provided by bd 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 bd.
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