No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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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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 a peeled outer layer on the distal cone of the balloon, confirming the investigation for peeled outer layer.An inflation attempt was made and a pinhole rupture was noted on the distal cone.The balloon was unable to be fully inflated.Therefore, the investigation is confirmed for the reported inflation issue as well as for a pinhole rupture.The identified pinhole rupture likely was the cause of the inflation issue, as a rupture would not allow the device to adequately pressurize.Because the peeling outer layer was noted at the location of the rupture, it is unknown if the rupture caused or contributed to the peeling outer layer.The definitive root cause for the identified issues 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.
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