A lot history review was conducted, and it was determined that a device history record (dhr) review was not required.The investigation is inconclusive for the reported balloon detachment, as the device was not returned for evaluation.The definitive root cause for the reported balloon detachment could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.The device is labeled for single use.
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This report summarizes one malfunction.A review of the reported information indicated that model atg80164 pta balloon dilatation catheter allegedly detached and migrated to the lungs.Forceps were used to retrieve the detached balloon.There was no reported patient injury.This information was received from one source.Patient age, weight, and gender were not provided.
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