Account reports after the proper balloon inflation and deflation technique was performed, when trying to remove the balloon from the sheath, it could not return through the 8 fr sheath.It inserted into the sheath with no difficulty, but it would not pull back through the 8fr sheath after the balloon had been inflated.The sheath had to be removed from the patient and a new 8fr sheath inserted because the balloon would not exit through the sheath.The patient had no complications, but this did cause unneeded procedure complications, increased procedure time and the use extra supplies.Investigation summary: this complaint could neither be confirmed, or the root cause determined.The device was not returned for evaluation.A review of the batch history records and process controls has been carried out.The units were processed to the correct validated parameters.All units from this batch were subjected to a 100% final inspection process, including 100% wet leak testing.All units were inspected under a 10x vision system and all observed defective units were removed.All manufacturing operations were completed by fully trained operators.The current inspection & testing controls in place are deemed effective.All associated batch records have been reviewed and no anomalies or unusual data readings have been noted during this investigation.This failure mode is documented in the design fmea.Conclusion: the root cause of this issue is currently unknown.
|
Customer reported to staff in the field that after the proper balloon inflation and deflation technique was performed, when trying to remove the balloon from the sheath, it could not return through the 8 fr sheath.It inserted into the sheath with no difficulty, but it would not pull back through the 8fr sheath after the balloon had been inflated.The sheath had to be removed from the patient and a new 8fr sheath inserted because the balloon would not exit through the sheath.The patient had no complications, but this did cause unneeded procedure complications, increased procedure time and the use extra supplies.
|