This report summarizes one malfunction.A review of the reported information indicated that model u415034 pta balloon dilatation catheter allegedly ruptured, detached, and was secured using a stent.There were no consequences to the one patient involved.This information was received from one source.The patient was an 85-year-old male who weighed 145 pounds.
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H10: the malfunction was reassessed for reportability and determined to be reportable, as a serious injury, and was reported under emdr 2020394-2019-04046.H10: the lot number for the one malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation identified material rupture and detached material.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.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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