H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one lutonix pta balloon dilation catheter was returned for evaluation.On visual evaluation, it was noted there were tears to the catheter shaft and also the balloon was ruptured at multiple sites.On microscopic observations, it appeared like tears on the shaft of catheter.On functional evaluation, in-house presto inflation device was used to inflate the balloon and water was noted to leaking form the catheter shaft.Therefore, the investigation for the reported material rupture is confirmed as the balloon has multiple tears noted on the device which returned for evaluation.Therefore, the investigation for the reported device damaged prior to use is confirmed as the returned device contain multiple tears on the catheter shaft noted under microscopic observation and water leaks during the functional evaluation.A definitive root cause for the alleged device damaged prior to use and material rupture could not be determined based upon the provided 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.H10: g3, h6 (method) h11: h6 (result, conclusion) 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.See h10.
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