|
It was reported, during angioplasty of a calcified lesion below-the-knee, an advance 14 lp low profile balloon catheter perforated longitudinally.The vessel was not angulated.According to the complainant, the inflation was approximately 8 to 16 atmospheres (atm) but not greater than burst pressure.A 6fr ansel sheath and wire guide were used in conjunction with the complaint device.The complaint advance 14 lp low profile balloon catheter was removed from the patient's anatomy and another was used to successfully complete the procedure.No patient adverse effect was reported.The patient did not retain any balloon fragment.
|
|
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, quality control, and a visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device revealed one pinhole rupture of the balloon material noted near the proximal marker band.This contradicts the reported longitudinal rupture.No other nonconformances were noted on the rest 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.However, during the review of the subassembly lot sa8600829, there were several different nonconformances noted.Seven of the devices failed the leak check during the quality control inspection, another two were found to have holes in the balloon material during production.All affected devices were scrapped and note replaced.It should also be noted there were no other reported complaints for this lot number.Furthermore, a review of the manufactures instructions and quality control procedures was conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which states ¿the balloon is intended for percutaneous transluminal angioplasty of lesions in peripheral arteries, and as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.It includes a warning against exceeding the rated burst pressure, which may result in rupture.¿ it goes on to say ¿to inflate the balloon to the desired pressure and to adhere to the recommended balloon inflation pressures.The ifu makes it known that particular care should be taken in handling the balloon to prevent damage.Upon opening and removing the device, inspection of the catheter is required to ensure no damage has occurred during shipping.¿ based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be traced to the device.The root cause may lie with the patient condition as vessel calcification was noted, and calcification could present with sharp edges.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.
|
