Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.A visual inspection found the balloon to be fully detached from the proximal and distal weld locations.Remnants of balloon material were noted at both weld locations, indicating a completed weld had been made.Therefore, the investigation is confirmed for a complete balloon detachment.Additionally, the inner guidewire lumen was found to be stretched.Therefore, based on the detached balloon and stretching of the inn lumen, the investigation is confirmed for the reported retraction issue.The investigation is also confirmed for dislodged marker bands as both bands were found to have dislocated distally on the inner lumen.The marker bands likely dislodged as the balloon detached distally.It is likely that the detachment of the balloon resulted in the retraction issues through the sheath.However, the definitive root cause for the identified balloon detachment could not be determined based on the available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.The information provided by bard 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 bard.
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