The advanta v12 was not returned for evaluation and no images of the device were provided.Multiple good faith efforts were made to obtain more detailed information and to request if the device was available for return without any success.The details provided indicate that "during the procedure, the carrier balloon tore off after the stent was released upon retraction and remained in the sheath.After that it could only be removed with this sheath.The balloon remained partially insufflated, so that its diameter was larger than that of the sheath the balloon was separated from the catheter shaft upon withdrawal back through the introducer sheath".Based on the details they suggest that the balloon had not been allowed sufficient time to deflate prior to withdrawing the balloon back into the introducer sheath.This is why the balloon was claimed to be "partially insufflated".If the balloon was not allowed the recommended time to deflate as indicated in the instructions for use, upon withdrawal of the balloon back into the introducer sheath the remaining fluid in the balloon gets pushed into the distal end of the balloon creating a bolus of fluid that could prevent the balloon from completely entering the sheath.The instructions for use specify the following in the deployment section line #6."deflate the balloon by pulling vacuum on the inflation device to its maximum volume for 40 seconds.Verify full balloon deflation via fluoroscopy before proceeding to step 7".The details also mention that the balloon was separated from the catheter shaft.The proximal balloon weld tensile data of the 20 samples were tested for the minimum tensile test force requirement of 15 newtons as documented in the product requirements specification.Based on the device history record review the minimum proximal balloon weld tensile strength of the 20 tested samples was 24.6 newtons which is well above the minimum specification requirement.Further review of the instructions for use states in the warnings and caution section line item #10."do not force passage or withdrawal of the guidewire or delivery system if resistance is encountered".For the shaft to break separating the balloon from the catheter shaft it is reasonable to conclude too much force was applied.As the details provided indicate, the advanta v12 covered stent was deployed indicating that the inflation lumens of the catheter were patent.A review of the balloon inflation skive dimensions as recorded in the device history record show that all dimensions were within specification.Based on the complaint details and device history record review the investigation cannot conclude that the balloon separation from the shaft was due to the design or manufacture of the product and it cannot be confirmed that the device was the cause of the reported complaint.
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