Concomitant medical product: boston scientific symmetry balloon catheter.Complaint conclusion: a slalom.018 hp 40 5 x 4 percutaneous transluminal angioplasty (pta) balloon catheter (bc) was inserted and inflated the lesion; however, it ruptured at around eight atmospheres (8atm).There was no reported patient injury.It was replaced with a non-cordis bc and the procedure was completed.The product was not returned for analysis.A product history record (phr) review of lot 17726074 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst-at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.There is no additional information regarding patient, lesion or procedural characteristics regarding this event.With the paucity of information available and without the return of the product or films of the procedure it is difficult to draw a clinical conclusion between the device and the event reported.However, vessel characteristics and procedural factors may have contributed to the reported event.According to the instructions for use, which are not intended to mitigate risk, ¿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.Caution: fully deflate the balloon by inducing negative pressure with the inflation system whenever the pta catheter is advanced or withdrawn.Do not advance or withdraw the pta catheter within the vasculature unless the catheter is preceded by a guidewire.Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.Remove the vacuum (do not apply pressure) and withdraw the catheter.Note: gentle counterclockwise rotation of the balloon may ease withdrawal from the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath or guiding catheter, check if the balloon is fully deflated.If not, withdraw the catheter and sheath as one unit.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
|
As reported, a slalom.018 hp 40 5x4 percutaneous transluminal angioplasty (pta) balloon catheter (bc) was inserted and inflated the lesion, however, it ruptured at around 8 atmospheres (atm).There was no reported patient injury.It was replaced with a non-cordis bc and the procedure was completed.
|