It was reported, during percutaneous transluminal angioplasty of the leg, "air wouldn't go into the balloon".It was said air was leaking out between the hub and catheter of the advance 14 lp low profile balloon catheter.Clarification has been requested for this report.Additionally it was reported patient demographics are unknown.The patient's anatomy was calcified.The complaint device was inflated with an unspecified mixture of contrast to saline using an unknown inflation device.The procedure was completed using another advance 14 lp low profile balloon catheter.The patient did not experience any adverse effects and the procedure was successfully completed.
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Investigation ¿ evaluation: reviews of the complaint history, device history record, documentation, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that no biological matter was noted.The balloon itself appeared to have been manipulated from the initial folding process and contained a clear liquid and substance of some sort.This information suggested that the device was prepped with a contrast medium, as originally reported.A syringe was connected to the balloon lumen and the plunger compressed to clear the device.There was no difficulty when applying pressure; however, leakage was confirmed between the hub and strain relief connection.Upon further inspection, a fracture was noted to run circumferentially around the hub.This separation was easily made visible by the adhesive used to reconnect the device which was also clearly separated along the same line.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states the ¿intended use outlines that it is for percutaneous transluminal angioplasty (pta) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.¿ it is also noted in bold that particular care should be taken in handling the balloon to prevent damage.Additionally, upon removal from package the catheter is to be inspected to ensure no damage has occurred during shipping.Based on the information provided and the examination of the returned product, investigation has concluded a root cause for this event could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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