It was reported that prior to a thrombectomy and atherectomy procedure, while loading the device on the wire, the tip of the device allegedly seemed floppy as like the helix was stretched or broken.The procedure was completed using another device.There was no patient contact.
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H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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.H3 other text : device pending return.
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