Complaint conclusion: as reported, the balloon of a 10mm x 4cm x 135 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter did not inflate when the physician went to inflate it.There was no reported patient injury.The product was returned for analysis.A non-sterile powerflex pro 10mm x 4cm 135 percutaneous transluminal angioplasty (pta) was received for analysis inside a plastic bag.Per visual analysis, no anomalies were observed by the naked eye.Per functional analysis, a lab sample inflator/deflator device partially filled with water was attached to the inflation lumen of the unit and pressure was applied.A balloon leakage was observed coming from a rupture in the middle section of the balloon.No other anomalies were observed.Per sem analysis, results showed that the leakage on the balloon of the powerflex pro 10mm x 4cm 135 device presented evidence of a ruptured condition and scratch marks near the damaged area on the balloon.This type of damage is commonly caused during the interaction of the material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the balloon could probably led to the damaged condition found on the received device.It seems the material near the damage was ruptured with a sharp object from the outside of the device.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82150601 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon inflation difficulty - unable to inflate¿ and subsequent findings of ¿balloon burst¿ were confirmed via device analysis as a leakage was noted due to a rupture on the mid portion of the balloon.The outer surface of the balloon presented evidence of scratch marks adjacent to the rupture noted.It is likely vessel characteristics and procedural factors, although unknown, contributed to the reported event as evidenced by device analysis.The balloon material near the rupture, appears to have been torn either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.According to the safety information in the instructions for use, ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.
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