It was reported, during a fistulagram procedure, the balloon of the advance 18 lp low profile balloon catheter was found to have a hole in it.This was discovered when the balloon was inflated and contrast was injected.The contrast leaked out of the balloon.The complainant denied any scarring, calcification, or tortuosity of the patient's anatomy.The advance 18 lp low profile balloon catheter was removed and the procedure was successfully completed using another.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
|
Investigation/evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of a pin hole leak, which was noted at a distance of 20.9 cm from the distal end of the device.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 be noted that there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.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.
|