H10: 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 received for evaluation.An attempt was made to inflate the device due to dried contrast in the inflation lumen.However, the shaft was cut and the device was inflated with a touhy-borst adapter, and water was seen leaking from the balloon.Fiber disturbance was noted at the location of the leak.The fibers were stripped, and a circumferential rupture was noted on the balloon.Therefore, the investigation is confirmed for a circumferential rupture and for fiber disturbance.However, the investigation is inconclusive for the reported deflation issue as the balloon was unable to be fully inflated and deflated due to dried contrast in the inflation lumen and balloon rupture.It is likely that the reported deflation issues were a result of the circumferential rupture.However, the definitive root cause for the identified rupture or fiber disturbance 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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