H10: the lot number for the malfunction was provided and a lot history review will be performed.The device has been returned for evaluation; the evaluation identified material perforation leading to partial deployment.Trending device code has been updated (1158 - failure to deploy, 2205 - material perforation, 2532 - misfire).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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